Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

SLNM and OSNA assessment of sentinel lymph nodes compared to ultrastaging

quantitative reverse transcription polymerase chain reaction (qRT-PCR) cytokeratin-19 detection in specimen (sentinel lymph node)

RD-100i, OSNA

Ondřej Topolčan, Prof. MUDr.

Zdeněk Novotný, Doc.MUDr.

The aim of the study is to compare one-step nucleic acid amplification method (OSNA) with histological ultrastaging examination in the sentinel lymph node assessment in patients with endometrial cancer.

The molecular biologic method OSNA is a modern way of metastatic spread detection in lymphatic nodes using quantitative reverse transcription polymerase chain reaction. Cytokeratin 19 (CK 19) was selected based on previous studies as the optimal mRNA marker (detected by OSNA).

The intraoperative identification and rapid assessment of sentinel lymph nodes by OSNA could help to improve the standards of care in endometrial cancer patients.

Method:

After the sentinel lymph node detection (ICG, 99m Tc or Bleu Patente) and sentinel node/nodes removal is performed, the node/nodes is/are cut in 2-mm slices parallel to short axis of the node. The odd-numbered blocks will be examined by the OSNA method and the even-numbered blocks will be examined by conventional histopathological methods including immunohistochemistry.

Statistical analysis to identify differences will be performed subsequently.

Samples of the tissue homogenate will be retained and may be used for further testing.

SLNM in Endometrial Cancer Combined With OSNA

Sentinel Lymph Node Mapping in Endometrial Cancer Patients Combined With One-step Nucleic Acid Amplification (OSNA)

Number of CK 19 copies will be assessed: 250-5000 micrometastasis, more than 5000 copies macrometastasis. This result will be compared to histological ultrastaging examination.

University Hospital Pilsen

Charles University, Czech Republic

MUDr.

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

PRO131921

Bill Ho, M.D.

This is an open-label, multicenter, Phase I/II study of the safety of escalating doses of single-agent PRO131921 in patients with chronic lymphocytic leukemia (CLL) who have relapsed after or were refractory to treatment with a purine nucleoside analogue-containing regimen. The trial will enroll in two phases: a Phase I dose-escalation portion and a Phase II expanded treatment cohort, with enrollment of additional patients in order to expand safety experience and collect preliminary anti-leukemia activity data.

A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

An Open-Label, Multicenter, Phase I/II Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Who Have Been Treated With a Purine Nucleoside Analogue-Containing Regimen

Genentech, Inc.

Urinary Bladder Neoplasms

Lymphocele

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Cysts

Coagulants

All Drugs and Chemicals

Hemostatics

1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.

Nicolaas Lumen, MD, PhD, FEBU

Pelvic lymph node dissection (PLND) is the most accurate staging tool to determine lymph node involvement in prostate and bladder cancer. The main complication of PLND is development of a lymphocele, which can cause symptoms including lower abdominal pain, leg or penile/scrotal edema, bladder outlet obstruction, deep venous thrombosis or infection/sepsis. The incidence of radiographic (asymptomatic) and symptomatic lymphoceles following PLND varies between 12,6-63% and 1,6-33% respectively. Medicated sponges such as Tachosil® are indicated in surgery for improvement of haemostasis and to promote tissue sealing. They could reduce lymphocele development by increased tissue sealing, due to a mechanical effect of the sponge itself and a lymphostatic effect of the included thrombin and fibrinogen. Our goal is to prospectively assess the lymphostatic effect of Tachosil(r) in patients undergoing transperitoneal PLND with or without radical prostatectomy or PLND with bladder cancer surgery.

Effect of TachoSil® on Incidence of Symptomatic and Radiographic Lymphoceles After Extended Pelvic Lymph Node Dissection in Prostate and Bladder Cancer.

Total cost includes: surgical procedure, hospitalization and possible complications up to the first month post-surgery.

Takeda

University Hospital, Ghent

Skin and Connective Tissue Diseases

Neoplasm Metastasis

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

bevacizumab combined with dose dense chemotherapy

Linnea I. Chap, MD

Marilyn Mulay, MSN

Linnea I. Chap, M.D.

This research focuses on women with breast cancer whose disease has not significantly progressed, but who have 5 or more lymph nodes involved. In this study subjects will receive bevacizumab, a drug which is FDA approved for colon cancer but not for breast cancer, in combination with a regimen of approved chemotherapy drugs known as "dose dense chemotherapy." The study will observe the effectiveness and tolerability of this regimen.

Approximately 200,000 women are diagnosed with breast cancer in the United States every year. A significant factor determining long-term survivability of breast cancer is whether or not lymph nodes, glands which cleanse and filter the body's fluids, are involved. Despite treatment with approved multiagent cytotoxic chemotherapy ("dose-dense chemotherapy"), women with breast cancer involving more than 4 axillary lymph nodes still have a high risk for recurrence.

Several dose-dense chemotherapy regimens are currently being compared in other studies, however, at this time there is no proof that one regimen is superior to another. Therefore, in an attempt to decrease metastases, prolong time to recurrence and improve overall survival, it is essential to develop novel therapeutic strategies. The use of inhibitors of angiogenesis represents a promising option.

Bevacizumab is the first angiogenesis inhibiting drug to be FDA approved, for the treatment of colon cancer. It is has also been studied alone in progressed lymph-node positive breast cancer and has shown moderate efficacy.

This study will observe the efficacy and tolerability of using bevacizumab in combination with an approved dose-dense chemotherapy regimen for 8 cycles, followed by 12 of bevacizumab alone. Patients may be on the study for up to 52 weeks if their disease has not progressed and the regimen is tolerated.

Dose-Dense Chemotherapy Plus Bevacizumab in High Risk Lymph Node Positive Breast Cancer: A Pilot Study

Dose-Dense Chemotherapy Plus Bevacizumab in High Risk Lymp Node Positive Breast Cancer: A Pilot Study

Chap, Linnea I., M.D.

Vaginal Neoplasms

Vaginal Diseases

Vaginal Cancer

Procedure where a very small amount (less than one tenth of a teaspoon) of a radioactive material is injected around the edge of the tumor in the vagina, followed immediately by the scan. The scan is done before the patient has surgery or begins radiation therapy.

Lymphoscintigraphy

Charles Levenback, MD

Primary Objectives:

1. Determine the feasibility of using pretreatment lymphoscintigraphy to identify the sentinel lymph node(s) in patients with vaginal cancer dispositioned to receive radiation therapy.
2. Determine the feasibility of using preoperative lymphoscintigraphy and intraoperative lymphatic mapping to identify the sentinel lymph node(s) in patients with vaginal cancer dispositioned to undergo surgery and bilateral lymph node dissection.

The treatment of vaginal cancer is usually surgical removal of the vaginal tumor with removal of lymph nodes in the groin and/or pelvis. Patients who are not eligible to receive surgery usually receive radiation therapy.

Lymph nodes are a common site for the spread of vaginal cancer. Lymphatic mapping has been used in patients with other types of cancer to identify the "sentinel" lymph node. The sentinel lymph node is the lymph node believed to be at greatest risk for spread of the cancer. If the sentinel node does not contain cancer cells, then the remaining lymph nodes are almost always cancer free.

This research study will find out if the sentinel node concept can be applied to patients with vaginal cancer. The sentinel lymph node will be identified using a scan called "lymphoscintigraphy". A very small amount (less than one tenth of a teaspoon) of a radioactive material is injected around the edge of the tumor in the vagina, followed immediately by the scan. The scan is done in the Nuclear Medicine Department of M. D. Anderson before the patient has surgery or begins radiation therapy.

The dose of radiation injected into the vagina is much less than the dose received from a chest x-ray and therefore there are no special precautions needed after the injection. If the treatment plan is surgery, a second injection of the radioactive material may be necessary on the day of the operation because the radiation fades quickly. Patients who receive radiation therapy will not need a second injection. The radiation oncologist might use the information collected from the scan to help with treatment planning.

For patients having surgery, a special hand held instrument that measures radioactivity (similar to a Geiger counter) is used to help identify the location of the sentinel lymph node before and after the operation begins. Blue dye is also used to find the sentinel node. This requires the injection of up to a teaspoon of material called Isosulfan Blue around the tumor in the vagina. This is done while the patient is under anesthesia. The surgeon can then identify the sentinel node by its color (blue) and by its level of radioactivity (using the gamma counter).

Patients will be notified of the results of the mapping and lymphoscintigraphy during their hospitalization or their first clinic visit, depending on whether or not they had surgery.

This is an investigational study. Eighteen patients will take part in this study. All will be enrolled at M. D. Anderson.

Lymphoscintigraphy in Patients With Vaginal Cancer

Lymphoscintigraphy and Selective Lymphatic Mapping in Patients With Invasive Vaginal Cancer

M.D. Anderson Cancer Center

Digestive System Diseases

Colorectal Neoplasms

Lymphatic Metastasis

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

Pharmaceutical Solutions

Methylene Blue

Enzyme Inhibitors

Methylene blue solution (50 mg in 30 ml of saline solution) was injected in the cannulated main supplying artery of the freshly removed specimen, ex vivo. Colorectal specimen was then processed in the routine pathological work-up way.

Colorectal specimens were processed in the routine pathological work-up way.

Methylene blue solution is injected ex vivo in the main supplying artery trunk of the freshly removed colorectal specimen. (50 mg in 30 ml saline)

Methylene blue injection

Balazs Banky, PhD

Nora Susztak, MD

Nodal staging holds both important prognostic and predictive value at colorectal cancer. Regional lymph nodes are located close to the primary tumor in the mesocolon / mesorectum. Current pathology and oncology standards require a separate examination of at least 12 lymph nodes each case to fulfill staging "accuracy" criteria.

In order to reach this number of lymph nodes, a precise surgical technique (total mesorectal excision or complete mesocolic excision), as well as a thorough pathological specimen work-up is needed.

The aim of the study is to investigate, if ex vivo intra-arterial methylene blue injection by the surgeon can help improving nodal harvesting effectivity of the pathologist, hence leading to a better staging and hopefully even to a better outcome in the long run.

In 2014-2015 two surgical centers randomised resected colorectal specimens in 1:1 ratio to methylene-blue injection arm and control (no injection) arm in a total of 200 consecutive cases. Both pathologic and oncologic treatment were led regardless of the injection, reports were just routinely saved in the routine medical documentation.

This retrospective study is designed to recall patient-related, surgery-related factors, as well as pathology reports including nodal staging from the medical databases. The investigators aim to find correlation between methylene blue "staining" and lymph node yield. In addition, the investigators plan to crossmatch methylene blue injection, as a process, with long term survival of the patients.

Background:

Colorectal Cancer is the second most common cause of death in Hungary. The most important prognostic and predictive factor of colorectal cancer is the stage of disease at the time of diagnosis. Precise staging, especially nodal staging is highly important for correct planning of oncotherapy, i.e. adjuvant chemotherapy. Nodal staging relies on the proper surgical removal of mesocolon/mesorectum belonging to the the affected colorectal segment, as well as on the thorough pathology work-up of the specimen.

Current quality standards require examination of a minimum of 12 lymph nodes in order to reliably report N0 stage.

Methylene-blue injection into the main supplying artery of the removed specimen is one of the simplest and most effective techniques described to aid pathologist in lymph node harvesting.

Technique of methylene blue injection:

First of all, surgeon need to en block remove the affected colorectal segment with its mesecolon/mesorectum. Then the surgeon isolates the main supplying artery and cannulated it with an appropriate-size canula.

Methylene blue solution (50 mg methylene blue diluted in in 30 ml saline) is prepared and injected into the freshly removed specimen via the canula until the blue solution appears on the cut edges of the specimen.

The specimen can be processed in a routine way (placed in 4% formaldehyde).

Aim of the study:

The aim is to investigate if the well described and in Western-European healthcare systems well tested technique (Methylene blue injection) can be effectively adapted in an overwhelmed, busy Eastern-European healthcare environment. (Other techniques, including pathology assistant are not affordable in this area.) Apart form testing diagnostic accuracy of the pathologist on specimens with and without methylene blue injection, the investigators would like to assess a potential survival benefit of the suspected improvement of staging effectivity.

Timing of the study:

Over a 20-month period of 2014 and 2015 two surgical centers in Hungary randomised their elective colorectal resection cases into interventional and control arms. Randomisation was performed with a 1:1 ratio at each site on 100-100 consecutive cases.

Further pathology work-up and reporting has been routinely performed without any specific effect on oncology follow-up or treatment. No specific data collection has been performed after the intervention.

This study aims to retrospectively select the 100-100 (total of 200) consecutive colorectal resection cases of the given time frame from the official hospital medical recording systems.

Pathology reports and other relevant patient clinical records will be collected and statistically assessed.

Ethical approval was requested and gained from the Medical Research Council, Hungary, for the retrospective analysis of patient data.

Statistical analysis:

Power analysis was performed to get the sufficient number of cases (200 cases in total).

Case Report Form The retrospectively included cases will be listed in a specific database on a safe medical server. Anthropometric, disease-specific, operation-specific and pathology report details will be extracted out of the official patient documentation system.

Patients will be included according to the known interventional interval and the operation type (elective colorectal resection). Cases in the database will be anonymized. No patient-identifying data will be recorded or given to the assessor of the study (statistician).

Five to six years ago specimens from a total fo 200 consecutive colorectal cancer resection cases were randomized into two groups: 1. main supplying artery was cannulated and injected with methylene blue solution, 2. no intervention, routine specimen handling.

Ex Vivo Intraarterial Methylene Blue Injection Improve Nodal Staging Accuracy in Colorectal Cancer

The Impact of ex Vivo Intra-arterial Methylene Blue Injection on Nodal Staging Accuracy and Survival in Colorectal Cancer.

Total number of lymph nodes examined by pathologist

Number of positive lymph nodes found by pathologist

Minimum Nr of 12 lymph nodes examined if reported N stage is N0, or positive lymph node=s) found

Minimum Nr of 12 lymph nodes examined by pathologist

Overall survival after operation (in months)

St. Borbala Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
SLNM in Endometrial Cancer Combined With OSNA	NCT02826291	Endometrial Can...	RD-100i, OSNA	18 Years -	Charles University, Czech Republic
A Trial of the Safety of Escalating Doses of PRO131921 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia	NCT00496132	Chronic Lymphoc...	PRO131921	18 Years -	Genentech, Inc.
Effect of TachoSil® on Incidence of Symptomatic and Radiographic Lymphoceles After Extended Pelvic Lymph Node Dissection in Prostate and Bladder Cancer.	NCT02001857	Prostate or Bla...	1 TachoSil hemo...	18 Years - 99 Years	University Hospital, Ghent
Dose-Dense Chemotherapy Plus Bevacizumab in High Risk Lymph Node Positive Breast Cancer: A Pilot Study	NCT00378638	Breast Cancer	bevacizumab com...	18 Years -	Chap, Linnea I., M.D.
Dose-Dense Chemotherapy Plus Bevacizumab in High Risk Lymph Node Positive Breast Cancer: A Pilot Study	NCT00378638	Breast Cancer	bevacizumab com...	18 Years -	Chap, Linnea I., M.D.
Lymphoscintigraphy in Patients With Vaginal Cancer	NCT00528034	Vaginal Cancer	Lymphoscintigra...	-	M.D. Anderson Cancer Center
SLNM in Endometrial Cancer Combined With OSNA	NCT02826291	Endometrial Can...	RD-100i, OSNA	18 Years -	Charles University, Czech Republic
Ex Vivo Intraarterial Methylene Blue Injection Improve Nodal Staging Accuracy in Colorectal Cancer	NCT04842968	Lymph Node Meta... Colorectal Canc...	Methylene blue ...	18 Years - 100 Years	St. Borbala Hospital
Dose-Dense Chemotherapy Plus Bevacizumab in High Risk Lymph Node Positive Breast Cancer: A Pilot Study	NCT00378638	Breast Cancer	bevacizumab com...	18 Years -	Chap, Linnea I., M.D.

Spots Global Cancer Trial Database for lymph

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

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