Neoplasms

Digestive System Diseases

All Conditions

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

anyone who will participate in colon screening at the Princess Grace Hospital in Monaco and who has signed the informed consent document

PROCODE is an interventional study of category 2 (non-medicinal product), with a minimal risks and restrictions, involving only one blood drawn at the screening of colon cancer.

progastrin

Georges GARNIER

Dosage of progastrin in asymptomatic person participating in colon cancer screening

For anyone who will participate in colon screening at the Princess Grace Hospital of Monaco and who has signed the informed consent document. A blood test will be performed in addition to the screening test to assess the rate of progastrin.

Interventional Research, at Risk and Minimal Constraints, Category 2

PROgastrine COlon DEpistage

Dosage of Progastrin in Asymptomatic Person Participating in Colon Cancer Screening

measuring the rate of progastrin in the blood

Centre Hospitalier Princesse Grace

ECS-Progastrin SA

Rare Diseases

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

A fasting blood sample will be taken on the day of the beginning and the day of the end of the radiotherapy and during the adjuvant chemotherapy (every 3 cycles). A follow-up will be performed for 9 months, with a blood sample taken every three months on the day of the follow-up MRI.

Evaluation of plasma hPG80 concentrations by fasting blood samples. A total of seven 5 mL blood samples will be taken: Before radiation therapy; at the end of radiation therapy; at cycle 3 of chemotherapy; at cycle 6 of chemotherapy; 3 months after the end of treatment; 6 months after the end of treatment; and 9 months after the end of treatment.

Blood sample

Xavier DURANDO, Pr

PROGLIO is a French mono-centric study with longitudinal follow-up, in which patients with high grade brain tumors will be included. Blood samples will be taken during their therapeutic follow-up to evaluate plasma concentrations of hPG80 (circulating progastrin).

hPG80 (Circulating Progastrin) as a Blood Biomarker for High-grade Glial Tumors

Pilot Study of hPG80 (Circulating Progastrin) as a Blood Biomarker for High-grade Glial Tumors

To evaluate plasma concentrations of hPG80 (circulating progastrin) during therapeutic and recurrence follow-up in patients with high-grade brain tumors.

To study hPG80 concentration according to tumor progression in patients with high-grade brain tumor

To evaluate the sensitivity of hPG80 concentration changes to irradiation in patients with high-grade brain tumor.

To compare the plasma expression level of hPG80 in patients with high-grade brain tumor to study interindividual variations around and during disease management.

ECS Progastrin

Centre Jean Perrin

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Immune System Diseases

Esophageal Neoplasms

Breast Neoplasms

Pancreatic Neoplasms

Melanoma

Prostatic Neoplasms

Stomach Neoplasms

Glioblastoma

Head and Neck Neoplasms

Carcinoma, Renal Cell

Lung Neoplasms

Carcinoma, Hepatocellular

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Lymphoma

Urinary Bladder Neoplasms

Liver Neoplasms

Lymphoma, B-Cell

Kidney Neoplasms

Endometrial Neoplasms

Carcinoma

Urogenital Neoplasms

Genital Diseases

Urogenital Diseases

Male Urogenital Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Astrocytoma

Urologic Neoplasms

Urologic Diseases

Uterine Neoplasms

Uterine Diseases

Kidney Diseases

Adenocarcinoma

Liver Diseases

Esophageal Cancer

Pancreatic Cancer

Ovarian Cancer

B-cell Lymphoma

Renal Cell Carcinoma

Stomach Cancer

Ovarian Epithelial Cancer

Lymphosarcoma

420 patients affected by different types of cancer and treated in a curative or a palliative intent. In total 17 cohorts will be open, including: breast cancer, head and neck carcinomas, renal cell carcinoma, prostate carcinoma, lung carcinoma, hepatocellular carcinoma, colorectal carcinoma, thyroid cancer, pancreatic adenocarcinoma, ovarian adenocarcinoma, glioblastoma, endometrial adenocarcinoma, bladder carcinoma, oesophago-gastric carcinoma, B-cell lymphoma, gastric carcinomas. Patients enrolled in curative intent treatment cohorts will never have been previously treated for their cancer. Patients enrolled in non-curative intent treatment cohorts will have never been treated for their metastatic cancers previously, or have developed advanced/metastatic diseases as relapses of localized cancers previously treated with curative intent therapeutic strategies. Other cohort will be open (stability cohorts) : nychtemer cohort and post-operative kinetic cohort.

Blood draws are realized at each steps of patient disease management. The volume of each blood drawn is 25 mL for progastrin measurements and 5 mL for the dosage of the other tumor markers. The frequency depend to the cancer and treatment administered :

* Baseline at diagnosis : Local radical treatment : within 24h before surgery, within 24h after surgery and at the post-surgery follow up visit
* Chemotherapy treatment : every 3 or 4 weeks
* Radiotherapy : start day and at the end of radiation ("end of treatment" visit)
* Palliative systemic treatment (only palliative cohorts) : every 3 to 12 weeks. Follow until the third progression or change of treatment line, or alternatively up to 5 years after inclusion
* In case of PD or TOX
* Follow up: at each visit scheduled (every 3 months) for the first 2 years, then every 6 months for 3 years
* Relapse : withdrawn from the study and last progastrin measurement. Patient could be enrolled in the non-curative intent cohort

Blood draws

Benoit YOU, MD

Sara CALATTINI

Francois DUCRAY, MD

Marielle GUILLET, MD

Philippe MERLE, MD

Thomas WALTER, MD

Mathieu PIOCHE, MD

Amandine BRUYAS, MD

Philippe CERUSE, MD

Lionel BADET, MD

Marion CORTET, MD

Christophe SAJOUS, MD

Gilles DEVOUASSOUX, MD

Lize KIAKOUAMA, MD

Michael DURUISSEAUX, MD

Lionel KARLIN, MD

Marion CHAUVENET, MD

Gilles FREYER, MD

Véronique TRILLET LENOIR, MD

Denis MAILLET, MD

Sophie TARTAS, MD

Nathalie BONNIN, MD

Julien PERON, MD

Olivia LE SAUX, MD

Philippe PAPAREL, MD

Olivier GLEHEN, MD

Naoual BAKRIN, MD

Stephane DALLE, MD

Mona AMINI, MD

Pierre Adrien BOLZE, MD

Sebastien COURAUD, MD

Progastrin is a pro-hormone that, in physiological conditions, is maturated in gastrin in G cells of the stomach. The role of the gastrin is to stimulate the secretion of gastric acids during digestion. It is also important for the regulation of cell growth of the gastric mucosal.

In a healthy person, progastrin is not detectable in the peripheral blood. However, progastrin is abnormally released in the blood of patients with different cancers (colorectal, gastric, ovarian, breast, cervix uterus, melanoma...) The gene GAST coding for progastrin is a direct target gene of the WNT/ß-catenin oncogenic pathway. The activation of this oncogenic pathway is an early event in cancer development.

Chronic activation of the WNT/ß-catenin oncogenic pathway occurs in almost all human solid tumors and is a central mechanism in cancer biology that induces cellular proliferation, blocking of differentiation leading to primary tumor growth and metastasis formation.

Progastrin measured in the peripheral blood of patients on treatments, could be a new powerful marker for diagnosis and prognosis at different stages.

Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients

Progastrin concentration in plasma samples will be measured with an ELISA Kit (CancerREAD LAB) provided by ECS Progastrin.

A nonlinear mixed effect model will be used to model the progastrin measurements done during treatments and follow-up of patients.The effect of each event (chemotherapy, surgery...) on the progastrin value and in the inter-individual variability of production and/or elimination rates of progastrin will be analyzed. Progastrin will be measured by ELISA, and the values will be expressed in pM.

Measures will be done depending on the treatment received. Chemotherapy, every 3 or 4 weeks. Oral treatments: every 3 to 12 weeks. Surgery or radiotherapy: before and after the treatment. Follow up: concomitantly to the visits scheduled for the regular follow up of the patients.

24 patients will be selected, upon their agreement and serum high levels, to enter in nychtemer (12 patients) or weekly (12 patients) cohorts. For the Nychtemer cohort, progastrin will be assayed at d1 at 8:00 am; 11:00 am; 2:00 pm; 5:00 pm; 8:00 pm and at d2 at 8:00 For the weekly cohort, progastrin will be assayed Day 1; Day 8; Day 15 and +/- Day 22; ideally on the same hour times. Progastrin will be measured by ELISA, and the values will be expressed in pM.

A nonlinear mixed effect model will be used to correlate individual values of progastrin (expressed in pM) with individual characteristic on the patient (hepatic function, as measured by the concentration of AST, ALT and bilirubin).

Measures will be done Chemotherapy, every 3 or 4 weeks. Oral treatments: every 3 to 12 weeks. Surgery or radiotherapy: before and after the treatment. Follow up: concomitantly to the visits scheduled for the regular follow up of the patients

A nonlinear mixed effect model will be used to correlate individual values of progastrin (expressed in pM) with individual characteristic on the patient (renal function, as measured by creatinin concentration and creatinin clearance).

Measures will be done Chemotherapy, every 3 or 4 weeks. Oral treatments: every 3 to 12 weeks. Surgery or radiotherapy: before and after the treatment. Follow up: concomitantly to the visits scheduled for the regular follow up of the patients

A nonlinear mixed effect model will be used to correlate the individual characteristics of the patient (age and gender) with progastrin concentration at the inclusion.

A nonlinear mixed effect model will be used to correlate genders with progastrin concentrations at the inclusion.

The relationships between the progastrin kinetics during and after treatment and overall survival will be analyzed. Analyses will be performed separately on patients with curative intent treatment and on patients with palliative intent treatment.

Measures wil be done At the end of the study (6 years for patients enrolled in curative intent and 5 years for patients enrolled in non-curative intent) or alternatively at the occurrence of progression or relapse.

The relationships between the progastrin kinetics during and after treatment and recurrence free survival will be analyzed. Analyses will be performed separately on patients with curative intent treatment and on patients with palliative intent treatment.

Measures wil be done At the end of the study (6 years for patients enrolled in curative intent and 5 years for patients enrolled in non-curative intent) or alternatively at the occurrence of progression or relapse.

The relationships between the progastrin kinetics during and after treatment and progression free survival will be analyzed. Analyses will be performed separately on patients with curative intent treatment and on patients with palliative intent treatment.

Measures wil be done At the end of the study (6 years for patients enrolled in curative intent and 5 years for patients enrolled in non-curative intent) or alternatively at the occurrence of progression or relapse.

The size of the tumor will be correlated to progastrin concentration at the time of cancer diagnosis

The ability of progastrin kinetics during the neoadjuvant period to predict the outcome of the surgery (complete or not) will be analyzed by a ROC curve. If applicable.

The ability of the progastrin kinetics to predict recurrence free survival (curative cohorts), will be based on parameters estimated with a PK/PD model able to characterize the early kinetics of progastrin during and after the end of treatment and during follow up.

The ability of the progastrin kinetics to predict progression-free survival (non-curative cohorts) will be based on parameters estimated with a PK/PD model able to characterize the early kinetics of progastrin during and after the end of treatment and during follow up

The ability of the progastrin kinetics to predict time to death will be based on parameters estimated with a PK/PD model able to characterize the early kinetics of progastrin during and after the end of treatment and during follow up

The ROC AUC will be compared between classical markers and the prograstrin. Logistic regression will be used to combine the classical marker(s) and the progastrin in order to estimate the diagnostic value of the marker combination.

progastrin, CA15-3, CA19-9, CA125, CEA, PSA and AFP concentration will be measured on blood sample taken at the inclusion.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PROgastrine COlon DEpistage	NCT03775473	Colon Cancer Sc... Healthy Person	progastrin	50 Years - 80 Years	ECS-Progastrin SA
hPG80 (Circulating Progastrin) as a Blood Biomarker for High-grade Glial Tumors	NCT05157594	Glial Cell Tumo...	Blood sample	18 Years -	Centre Jean Perrin
Predictive Value of Progastrin Titer at Diagnosis and of Progastrin Kinetics During Treatment in Cancer Patients	NCT03787056	Cancer Breast Cancer Gastric Cancer Renal Cancer Prostate Cancer Melanoma Lung Cancer Hepatocellular ... Colorectal Canc... Head and Neck C... Pancreatic Canc... Ovarian Cancer Glioblastoma Endometrial Can... Bladder Cancer Esophageal Canc... B-cell Lymphoma	Blood draws	18 Years -	Hospices Civils de Lyon

Spots Global Cancer Trial Database for progastrin

Every month we try and update this database with for progastrin 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 progastrin

Every month we try and update this database with for progastrin 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 progastrin 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.