Neoplasms

All Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Thyroid Neoplasms

Thyroid Diseases

Carcinoma, Medullary

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Carcinoma, Neuroendocrine

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Adenocarcinoma

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Thyroid Cancer, Medullary

Neuroendocrine Tumor

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All Drugs and Chemicals

Anti-Dyskinesia Agents

Bone Density Conservation Agents

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Antibodies

Levodopa

Immunoglobulins

Calcitonin

Salmon calcitonin

Calcitonin Gene-Related Peptide

Katacalcin

Dihydroxyphenylalanine

Dopamine

Dopamine Agents

Neurotransmitter Agents

Antiparkinson Agents

PET performed 30 minutes after IV injection of 4 MBq/kg of 18F-DOPA

18F-L-DOPA PET

Badia-Ourkia HELAL, MD

Medullary thyroid carcinoma (MTC) is a rare tumor arising from C cells of the thyroid gland and belonging to the endocrine tumors. 18F-DOPA PET, based on tha capacity of endocrine tumor cells to take-up, decarboxylate and store amino-acids, such 3-4-dihydroxyphenylalanine(DOPA), is used for imaging endocrine tumors. The aim of the study was to evaluate the contribution of 18F-DOPA whole-body PET for the detection of recurrences in patients with proven recurrent MTC without evidence of recurrence or metastases on several imaging modalities.

In patients MTC and persistently elevated calcitonin levels, the challenge is finding the site of residual disease. Since the only satisfying treatment is surgery, the early detection and precise location is important. Tumor localization techniques usually performed, including ultrasonography of the neck and liver, chest and abdomen, bone scintigraphy, isotopic scanning and even PET with FDG are poorly sensitive. The use of 18F-DOPA may be more sensitive and specific engineering for localization metastatic disease. The study include 100 patient with persistent MTC demonstrated by elevated tumor markers (calcitonin and CEA) and no evidence of recurrence on morphological imaging procedures. 18F-DOPA whole-body PET is performed 30 minutes after IV injection of 4 MBq/kg of 18F-DOPA, the patient fasted for 6 hours prior the start of the examination.

All 18F-DOPA PET are evaluated independently by two experienced nuclear medicine physicians and any tracer accumulation exceeding the normal uptake tissue is rated as pathologic finding. The sensibility and efficiency of 18F-DOPA PET will be analysed and Malignant tissue confirmed by histology after surgery or biopsy or by follow-up for one year.

Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer

Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer.

Assistance Publique - Hôpitaux de Paris

Zakia.IDIR

Gastrointestinal Agents

Antihypertensive Agents

Sacubitril and valsartan sodium hydrate drug combination

Gastrins

Cholecystokinin

Valsartan

Angiotensin Receptor Antagonists

First intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N without and second injection with additional medication of Sacuitril (100 mg Entresto)(crossover)

First intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N with and second injection without additional medication of Sacuitril (100 mg Entresto)(crossover)

Intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N with and without co-medication with Sacuitril (100 mg Entresto) in each patient

177Lu-PP-F11N

Medication with Sacuitril (100 mg Entresto) additional to the injection of 177Lu-PP-F11N

Sacuitril

Christof Rottenburger, Dr. med.

Damian Wild, PhD Dr

The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of patients with advanced medullary thyroid carcinoma (MTC). 177Lu-PP-F11N is a gastrin analogon, binding to cholecystokinin-2 receptors. This receptors show an overexpression on more than 90 % of medullary thyroid carcinomas.

A phase 0 study (Lumed study part A) was already performed, showing low toxicity of 177Lu-PP-F11N and tumor uptake in all patients. Co-injection of Physiogel (Gelofusin) showed insignificant reduction of kidney uptake and can therefore be omitted for a radionuclide therapy with 177Lu-PP-F11N. In this study, the effect of the NEP-1 inhibitor Sacuitril on the in-vivo stability of 177Lu-PP-F11N and the uptake, respectively radiation doses in MTC metastases and organs will be evaluated, using a cross-over design already used for the Lumed part A study. Each patient will receive two injections of 177Lu-PP-F11N, with and without additional medication with Sacuitril Imaging findings, acquired by SPECT/CT, will be compared to imaging with 68Ga-DOTATOC positron emission tomography (PET)/CT. The inclusion of 8 patients is planned.

Group 1 patients will receive first 177Lu-PP-F11N alone, second 177Lu-PP-F11N in combination with Sacuitril. Group 2 patients will first receive 177Lu-PP-F11N in combination with Sacuitril, second 177Lu-PP-F11N alone. Affiliation of patients to Groups 1 and 2 will be randomised.

177Lu-PP-F11N in Combination With Sacubitril for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer

177Lu-PP-F11N in Combination With Sacubitril for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer (Lumed Phase 0/B)

Chromogranin A blood values will be compared to the radiation doses of the stomach.

Comparison of tumor imaging by 68Ga-DOTATOC PET/CT and 177Lu-PP-F11N SPECT/CT

Evaluation of the radiation doses in tumor tissue from MTC after injection of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto)

Evaluation of the radiation doses in the kidneys and the tumor-to-kidney dose ratios after injection of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto)

Evaluation of the radiation doses in other organs and the appropriate organ-to-kidney dose ratios after injection of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto)

Measurement (HPLC) of the in-vivo stability of 177Lu-PP-F11N alone and in combination with Sacuitril (Entresto).

In case of surgery with available tumor tissue samples, imaging results will be compared with autoradiographic analysis of somatostatine- and CCK2-receptor expression in tumor tissue.

Krebsforschung Schweiz, Bern, Switzerland

Center for Proton Therapy, Paul Scherrer Institute, Villigen,Switzerland

University Hospital, Zürich

University Hospital Freiburg

University Hospital, Basel, Switzerland

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Lung Neoplasms

Thymoma

Thymus Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Hormones

Hormone Antagonists

Phase 0: 6 patients, intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N with and without Physiogel (crossover)

Phase I: expected 12 - 18 patients, intravenous application of max. 6 x 7-8 GBq 177Lu-PP-F11N (increasing number of applications by one in groups of three patients). All patients with or without Physiogel, depending on the results of the phase 0 study.

Damian Wild, Prof Dr Dr

The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of patients with advanced medullary thyroid carcinoma (MTC). 177Lu-PP-F11N is a gastrin analogon, binding to cholecystokinin-2 receptors. This receptors show an overexpression on more than 90 % of medullary thyroid carcinomas.

In the pilot (phase 0) study investigators will correlate the tumour detection rate with the surgery and histology (proof of concept study). Furthermore, kidney protection and dosimetry studies will be performed in order to determine the kidney protection protocol and starting activity for the dose escalation study in the following, dose escalation (phase I) study. In the phase I study investigators will determinate the maximum tolerated dose of 177Lu-PP-F11N in patients with MTC. Furthermore, correlation with tumour radiation dose and treatment response as well as organ radiation doses and maximal tolerated dose will be performed in order to allow prospective individual patient tailored therapy planning. In the phase I study, participation is additionally possible for patients with well differentiated GEP-NET (grade 1-3) with a Ki67 index of up to 55% or NET of the lung or thymus (grade 1 and 2).

177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer.

177Lu-PP-F11N for Receptor Targeted Therapy and Imaging (Theranostics) of Metastatic Medullary Thyroid Cancer - a Pilot and a Phase I Study.

Phase 0 study: Evaluation of the scintigraphic visualisation of metastases after test injection, verification of 177Lu-PP-F11N uptake in metastases and correlation with surgery/histology if possible (poof of principle study).

Phase I study: Determination of the maximum tolerated dose (MTD)

Evaluation of the kidney radiation dose and the tumour-to-kidney radiation dose ratios with and without kidney protection (Physiogel). Composite measure.

Calculation of tumour and organ radiation doses.

Evaluation of in vivo stability of 177Lu-PP-F11N.

Measurement of the metabolites of 177Lu-PP-F11N with and without Physiogel infusion.

Evaluation of side reactions of 177Lu-PP-F11N.

Evaluation of biochemical response (decrease of calcitonin and calculation of calcitonin doubling time).

Evaluation of morphological therapy response (RECIST criteria).

Determination of the tumour detection rate and correlation with surgery/histology, if possible.

Calculation of organ radiation doses after therapy and correlation with the determined MTD (composite measure).

Determination of overall survival of patients after therapy.

Measurement of the metabolites of 177Lu-PP-F11N.

Symptoms and General Pathology

Recurrence

Amino Acids

Other Dietary Supplements

Vaccines

N-Methylaspartate

Aspartic Acid

Brewer's Yeast

Asparagine

6 months of surveillance followed by GI-6207 for 1 year

GI-6207 is a heat-killed, recombinant yeast-based vaccine engineered to express the full length human carcinoembryonic antigen (CEA), with a modified gene coding sequence to code for a single amino acid substitution (asparagine to aspartic acid) at the native protein amino acid position 610, which is designed to enhance immunogenicity. A plasmid vector containing the modified human CEA gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wild-type yeast) to produce the final recombinant vaccine product.

GI-6207 [Recombinant Saccharomyces cerevisiae-CEA (610D)]

Background:

- GI-6207 is an experimental cancer vaccine made with baker's yeast. The yeast has been modified to help the immune system target a protein called CEA. CEA is found on the surface of some kinds of tumor cells, including thyroid cancer cells. Researchers want to see if GI-6207 can encourage the body's immune system to attack and kill tumor cells that contain the CEA protein. They will test to see whether this vaccine is a safe and effective treatment for medullary thyroid cancer that has not responded to earlier treatments.

Objectives:

- To test the safety and effectiveness of the GI-6207 vaccine for advanced medullary thyroid cancer.

Eligibility:

- Individuals at least 18 years of age who have medullary thyroid cancer that has not responded to earlier treatments.

Design:

* Participants will be screened with a physical exam and medical history. They will provide blood and tumor samples and have an imaging study of the neck and chest. They will also have a skin test to make sure that they are not allergic to the yeast in the vaccine.
* Participants will be divided into two groups. One group will start to take GI-6207 immediately for 1 year. The second group will have 6 months of monitoring and tests with no vaccine, and then will take GI-6207 for 1 year.
* GI-6207 will be given every other week for the first seven visits (about 3 months), and then monthly for the remaining year of treatment. It will be given as injections beneath the arm and in the upper thigh. These locations will help the vaccine enter the lymph nodes and reach the immune system more quickly.
* Participants will be monitored with frequent blood and urine tests and imaging studies.
* Participants will have regular follow-up visits after their year of study vaccines.

BACKGROUND:

* CEA is overexpressed in multiple malignancies, including medullary thyroid cancer where CEA is universally expressed on tumor cells.
* There is no standard treatment for patients with asymptomatic or minimally symptomatic, metastatic medullary thyroid cancer. The only effective FDA-approved therapy (vandetanib) comes with significant toxicity, so it is not used until patients have symptomatic or rapidly progressing disease.
* Preclinical studies have shown that GI-6207 can induce a strong immune response to CEA as well as therapeutic anti-tumor responses.
* A previous Phase I GI-6207 study has demonstrated safety and enhanced immune response in some patients.
* Preliminary data suggests that tumor growth rates can be calculated in medullary thyroid cancer patients within 3 months
* Retrospective data from prostate cancer studies suggest that vaccines can alter tumor growth rates within 3-4 months

OBJECTIVES:

Primary:

-To determine the effect of GI-6207 on calcitonin growth rate kinetics after 6 months of therapy in patients with medullary thyroid cancer

ELIGIBILITY:

* Patients will have evidence of metastatic medullary thyroid cancer including disease that is evaluable on bone or CT scan.
* Patients with minimal or no disease related-symptoms (minimal symptoms will include those that do not affect activities of daily living or pain that does not require regularly schedule narcotics.)
* ECOG 0-1
* No previous chemotherapy
* No previous vandetanib
* Should have no autoimmune diseases; no evidence of being immunocompromised; no serious inter-current medical illness; no cardiac disease; no prior splenectomy. (History of previous thyroid autoimmune disease will be allowed as these patients will have had total thyroidectomy.)
* No brain metastasis, history of seizures, encephalitis, or multiple sclerosis
* No pericardial-based masses greater than 1 cm or thoracic lesions larger than 2 cm

Design:

* Randomized, phase 2 study to determine the effect of GI-6207 on calcitonin growth rate after 6 months of GI-6207
* Patients will be randomized to either initial GI-6207 therapy or 6 months of surveillance followed by GI-6207 therapy.
* GI-6207 will be administered subcutaneously at 4 sites at dose of 10 yeast units per site, biweekly for 7 visits (day 1, 15, 29, 43, 57, 71, 85), then monthly up to 1 year of treatment. (For patients randomized to surveillance and then GI-6207, they will get a full year of GI-6207 after a 6 month surveillance period.)
* Once patients have completed one year of therapy with GI-6207, patients without radiographic progression will have the option to receive vaccine every 3 months for an additional 12 months. Patients who remain on vaccine will continue to be scanned every 3 months.
* Immune monitoring via apheresis will be done prior to enrollment and at 6 months for all appropriate and consenting patients. Patients who are evaluable for immunologic response by the ELISPOT Assay (HLA 02, 03 and 24) will have apheresis at start of GI-6207 therapy and then every 3 months while on GI-6207 treatment when feasible.

QUILT-3.006 for Recurrent Medullary Thyroid Cancer

A Phase 2 Study of GI-6207 in Patients With Recurrent Medullary Thyroid Cancer

National Cancer Institute (NCI)

NantCell, Inc.

Goiter

Goiter, Nodular

Calcium

Calcium, Dietary

• Cases: Patients who meet the above inclusion and exclusion criteria and have a diagnosis of medullary carcinoma by histology

Controls: Patients who meet the above inclusion and exclusion criteria and do not have a diagnosis of medullary carcinoma by histology.

Fine needle aspiration (FNA) nodule biopsy: FNA is performed on each patient as long as ATA guideline criteria is met. In case of suspicion of medullary carcinoma, in search of a nodule or medullary focus, FNA will be performed on all non-cystic or spongiform nodules larger than 0.8 cm.

Fine Needle Aspiration Cytology (FNAC) procedure+calcitonin measurement

Medullary thyroid carcinoma (MTC) is a tumor originating from parafollicular C cells of the thyroid. (1) Representing 1 to 7% of all thyroid carcinoma cases (2, 3, 4). It can occur in two clinical forms, the sporadic or non-hereditary, in 75-80% of patients, and the hereditary form in the remaining 20-25%. It can be part of different clinical syndromes depending on the organs involved: Multiple Endocrine Neoplasia type 2A (MEN2A), Multiple Endocrine Neoplasia type 2B (MEN2B) and Familial Medullary Thyroid Carcinoma (FCM) whose clinical expression is only CMT. A distinctive characteristic of this tumor is its capacity to secrete calcitonin (CT), which, measured in serum, sanctions suspicion of this pathology (5-8) leading to diagnostic studies to confirm CMT. For the preoperative diagnosis of thyroid nodules, ultrasound-guided fine-needle aspiration cytology (FNAC) is a useful and safe procedure; however, its sensitivity to exclude CMT is low (9-15). In 2015, a meta-analysis of 15 studies (16) found that the accuracy of FNAC in diagnosing CMT was around 50%. For this reason, other studies have indicated that the measurement of calcitonin in the fine-needle lavage aspirate fluid of thyroid nodules (CT-guided FNAC), which have suspected medullary carcinoma, can significantly improve the accuracy in the diagnosis of MTC (17 -19). Therefore, clinical practice guidelines recommend its determination in patients with suspected MTC (1,2). The diagnostic importance of pre-surgical medullary carcinoma lies mainly in two points: first, it changes the surgical approach of the patients, and second, it allows one to rule out associated pathologies such as hyperparathyroidism and pheochromocytoma, which are associated when the entity is hereditary. The performance of CT-guided FNAC by the chemiluminescent (CL) method has been widely disseminated. However, to the best of our knowledge, to date there are no data available on the appropriate cut-off value of CT-guided FNAC with calcitonin electrochemiluminescence (ECL) immunometric assay method. As previously stated, it is of particular interest to determine the calcitonin cut-off point in needle washing by electrochemiluminescence method that allows diagnosing medullary carcinoma. Clarifying this point allows improving the approach to patients in whom medullary carcinoma is suspected. This work seeks to determine the cut-off point of CT-guided FNAC for the diagnosis of CMT with the ECL assay method.

Investigative Question:

In daily practice, what value of calcitonin in needle washing by electrochemiluminescent method allows the diagnosis and localization of medullary carcinoma in patients with thyroid nodules with suspected medullary carcinoma? Primary Objective: To determine the cut-off point of calcitonin in fine needle washing of puncture aspiration of thyroid nodules (CT-guided FNA) for diagnosis and localization of medullary carcinoma.Sample Size: Fifty patients with medullary carcinoma and 105 controls will be included. For each case, two controls will be selected, matched by age, sex and non-medullary nodular pathology. In order to estimate the prevalence of medullary carcinoma in patients of the population studied,in whom calcitonin is routinely determined with an accuracy of +/- 2% and a confidence levelof 95%, it is necessary to study 105 patients according to the formula: Study Design: Observational case-control study (patients with medullary carcinoma versus patients without medullary carcinoma). The decision of this design model was due to the low prevalence of medullary carcinoma in the population of patients with thyroid nodules. Methodology: The manuscript followed STARD guidelines for reporting observational and diagnostic studies. Location and Time Period: This multicenter study will be carried out in Argentina including variables obtained from 01.03.2018 to May 31, 2022.Coordinating Institution:- Hospital Universitario Austral: Dr. Cavallo Andrea.- Other study centers invited to participate: Sanatorio Las Lomas San Isidro, and the-Hospital Alta Complejidad Formosa. Dr. Andrea Cavallo will be the principal investigator in the three centers. Patients:A prospective database of patients with punctured thyroid nodules and with serum determination of calcitonin according to the annex presented, as an annex, will be carried out. Patients ≥ 18 years of age, with nodular or multinodular goiter who are undergoing surgery, with normal or elevated serum calcitonin and/or with suspected CMT due to RET mutation from 3/1/2018 to 5/31/2022 will be selected according to inclusion criteria. Patients who do not have a remaining puncture sample, without serum calcitonin, not referred to surgery or those who are lost upon follow-up, will be excluded. The study will be carried out in the Endocrinology Service (Endocrinology area of the Hospital Universitario Austral, Pilar; Hospital Alta Complejidad, Formosa; and Sanatorio Las Lomas, San Isidro). Selection Criteria for Cases and Controls: • Cases: Patients who meet the above inclusion and exclusion criteria and have adiagnosis of medullary carcinoma by histology. • Controls: Patients who meet the above inclusion and exclusion criteria and do not havea diagnosis of medullary carcinoma by histology.For the control group, patients will be randomly selected in a 1:2 ratio, adults, with nodular or multinodular goiter without hypercalcitoninemia, who have surgical criteria. FNA will be performed according to ATA recommendations and with residual sample of FNA washing fluid for calcitonin. It is estimated to include a sample of 100 patients in the control group. Study Variables-Primary Results: The diagnosis of medullary carcinoma is defined according to guidelines of the American Society of Pathologists that uses the Pathological Anatomy service as a diagnostic basis. DATA COLLECTION AND PROCEDURES: In all three institutions the diagnostic work-up of a thyroid nodule includes the combination of personal and family history, physical examination, evaluation of thyroid function, and thyroid US. FNAB is performed following the ATA guidelines recommendations. The data will be obtained from the medical records of the patients (according to authorization requested for the creation of the database) through observation record sheets in Excel (Microsoft). Serum calcitonin test: CT is measured with the same commercially available ECLIA method at the three participating institutions. The determination of calcitonin was carried out on a Cobase601 autoanalyzer with the Elecsys® Calcitonin test (Roche Diagnostics), an electrochemiluminescent immunoassay (ECLIA). As reported by the manufacturer, this test has a detection limit of 0.5 pg/ml, a referenceinterval of up to 9.8 pg/ml for women and 14.3 pg/ml for men, and a measuring range from 0.5to 200,000 pg/ml. Standardization of serum calcitonin sampling and needle washing (in the three institutions) The harmonization of the pre-analytical stage for serum calcitonin determination was ensured in all three centers. This involved morning blood extraction, an 8-hour fasting period, and the collection of fresh serum following laboratory-specific centrifugation protocols. Fresh samples were promptly processed. All centers utilized the same assay for analysis. Evaluation of nodules by ultrasound: All nodules are routinely analyzed in terms of size, echogenicity, number, margin, structure (solid, mixed, or cystic), presence of microcalcifications, and vascularity. According to the ultrasound characteristics, of the American Thyroid Society (ATA). Fine needle aspiration (FNA) nodule biopsy: FNA is performed on each patient as long as ATA guideline criteria is met. In case of suspicion of medullary carcinoma, in search of a nodule or medullary focus, FNA will be performed on all non-cystic or spongiform nodules larger than 0.8 cm. Cytological Analysis: The cytological study will be carried out by expert pathologists, biased to the value of serum Routine Fine Needle Aspiration Cytology (FNAC) procedure: A 23G gauge needle is used under ultrasound guidance. After the smear, the remaining syringe and needle used for washing will be rinsed with 0.5 ml of normal saline. The aspirate will be subjected to calcitonin measurement (all determinations are made in residual fluid sample from the FNA) and will be processed immediately. Definition of hypercalcitoninemia in serum: Female patients with calcitonin levels ≥ 9.8 pg/ml and male patients with calcitonin levels ≥ 14.3 pg/ml. To confirm hypercalcitoninemia, all patients must have at least two serum determinations (it is routinely performed in daily clinical practice as recommended by clinical practice guidelines). The following variables will be verified: a) Inclusion date b) Sexc) Age d) Presentation (nodular or multinodular goiter) e) Number of nodules, location f) Thyroid function (hypothyroidism, hyperthyroidism, Hashimoto's thyroiditis) g) Description of thyroid nodule (echogenicity, margins, consistency, location, presence of calcifications, size) h) Type of thyroid carcinoma (differentiated, medullary, anaplastic, and its variants). Medullary carcinoma was ruled out if Ctn was ≤9.8 pg/mL for women and ≤ 14.3 pg/mL for men, those patients with calcitonin levels ≥ 9,8 pg/mL for women and ≥ 14.3 pg/mL for men and ≤50 pg/mL , were considered as harbouring a low risk for MTC, those with calcitonin ≥ 50 pg/mLl and ≤100 pg/mL, with a moderate risk and those with calcitonin ≥100, with a high risk for MTC 25. In all cases of hypercalcitoninemia, other causes of non-medullary hypercalcitoninemia were ruled-out; first, We repeated serum calcitonin two times throughout the study to minimize the risk of false positives and false negatives attributable to the biochemical test we conducted a comprehensive medical history assessment to identify any underlying conditions that could be responsible for elevated calcitonin levels. This assessment involved using a designed checklist for medications and diseases. To evaluate these conditions, we requested (laboratory tests,. clinical signs, FNA, and pathological examinations).FNAC result (bethesda and cytological description), for each punctured nodule.Pathological anatomy result. TNM and stageSerum calcitonin.Calcitonin in lavage of each punctured nodule. To obtain anatomical, cytological and anatomopathological correlates, each surgical piece was analysed according to the ultrasound data of each patient. Biochemical determinations: TSH, T4l, antithyroid antibodies, calcium, Vit D, PTH, urea, creatinine, clearance, hepatogram, blood count, thyroglobulin.Mortality at last visit Anatomo-pathological analysis: It will be carried out according to standardized norms, in case of doubts or discrepancies they will be resolved internally by three pathologists from each institution. To correlate nodule/spinal focus, an ultrasound correlation (with nodule numbering, cytology, calcitonin in lavage and histology) will be performed in all patients. Possible Biases and Confounding Variables • Selection bias: To avoid this bias in the selection of cases and controls, subjects are followed and treated under the same standards of care. o Cases and controls will be selected by the investigator of the research study (already defined above). • To avoid biochemical determination bias: all determinations will be made using the same procedure, and with the same brand of device. Statistical Analysis Plan For descriptive analysis, continuous variables will be expressed as mean and standard deviation or median and interquartile range (IQR), depending on the observed distribution. The continuous variables were compared by Student's Test for independent samples, one-factor ANOVA or the Mann-Whitney test in case of not complying with the assumptions of normality. To compare qualitative variables, the independence test (Chi-squared) will be used. A clinically relevant cutoff point will be selected to calculate sensitivity, specificity, NPV and PPV and their respective 95% CIs. In all cases, a significance level of less than 5% will be used from the statistical tests applied to reject the hypothesis. The sample will be divided into two groups, those with hypercalcitoninemia, and patients without hypercalcitoninemia that will constitute the control group. ETHICAL ASPECTS The protocol will be sent to the Research Ethics Committee (REC) or Teaching and Research Committee for review and approval. Clinical research will comply with the ethical guidelines indicated in the Declaration of Helsinki of the World Medical Association, in the International Ethical Guidelines for Biomedical Research of the Council for International Organizations of Medical Sciences and in the UNESCO Declaration on Bioethics and Human Rights. (the information cannot be associated, outside of scientific reasons, with a specific person or person. determinable). All data obtained from the study will be handled confidentially and will be available for monitoring if requested by REC participants. If it is necessary to make modifications to what is written in the protocol during the development of the research, new approval will be requested from the REC. The REC can actively monitor the study, ensuring compliance with laws and principles of research ethics. A waiver of informed consent is expected for participating patients beyond that already obtained during medical procedures according to routine practice, since punctures will be performed in nodules larger than 0.8 cm in search of spinal focus in those with hypercalcitoninemia and, in addition, data will be collected from their medical records, according to the request for approval of the creation of the database presented as an annex. This study has no external funding. The selection and inclusion of institutions, data analysis and the results of the different stages of this project will be carried out by the research team described above. Expected Results The determination of the calcitonin cut-off point in needle lavage in patients with thyroid nodules from the general population for the diagnosis of medullary carcinoma is clinically relevant data. Its determination in this population is seldom studied, due to the low incidence of medullary carcinoma in the population of patients with nodular pathology; determining it will allow improvement of the management of patients in daily clinical practice. Therefore, the results are expected to be extremely important for medical science around the world. As mentioned above, there is no work in world literature that determines the cut-off point for calcitonin in lavage in the general population of patients with thyroid nodules for the diagnosis ofm medullary carcinoma. The determination of calcitonin in needle wash is a simple, non-invasive, low-cost method and the results are very precise; and its modulation through the use of a cut-off point has the potential to guide which patients would and would not benefit from a surgical procedure. We believe that this research question will be answered through this multicenter, case control study

Calcitonin in Needle Wash Using Electrochemiluminescence Method For Diagnosis Of Medullary Thyroid Carcinoma.

Optimizing Diagnostic Accuracy of Fine Needle Aspiration Biopsy Calcitonin Measurements in Detecting Medullary Thyroid Carcinoma

all collected IPD, all IPD that underlie results in a publication

The diagnosis of medullary carcinoma is defined according to guidelines of the American Society of Pathologists that uses the Pathological Anatomy service as a diagnostic basis.

Sensitivity, specificity, and the area under the receiving operator curve (AUROC) were calculated for patients and for the total number of thyroid nodules

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer	NCT00647140	Thyroid Neoplas... Thyroid Carcino... Medullary Carci...	18F-L-DOPA PET	18 Years -	Assistance Publique - Hôpitaux de Paris
Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer	NCT00647140	Thyroid Neoplas... Thyroid Carcino... Medullary Carci...	18F-L-DOPA PET	18 Years -	Assistance Publique - Hôpitaux de Paris
177Lu-PP-F11N in Combination With Sacubitril for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer	NCT03647657	Thyroid Cancer,...	177Lu-PP-F11N Sacuitril	18 Years - 64 Years	University Hospital, Basel, Switzerland
177Lu-PP-F11N in Combination With Sacubitril for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer	NCT03647657	Thyroid Cancer,...	177Lu-PP-F11N Sacuitril	18 Years - 64 Years	University Hospital, Basel, Switzerland
177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer.	NCT02088645	Thyroid Cancer,... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ...	177Lu-PP-F11N	18 Years -	University Hospital, Basel, Switzerland
QUILT-3.006 for Recurrent Medullary Thyroid Cancer	NCT01856920	Medullary Thyro...	GI-6207 [Recomb...	18 Years - 100 Years	NantCell, Inc.
Calcitonin in Needle Wash Using Electrochemiluminescence Method For Diagnosis Of Medullary Thyroid Carcinoma.	NCT06067594	Medullary Thyro... Nodular Goiter	Fine Needle Asp...	18 Years -	Austral University, Argentina

Spots Global Cancer Trial Database for calcitonin

Every month we try and update this database with for calcitonin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for calcitonin

Every month we try and update this database with for calcitonin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for calcitonin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.