Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Peripheral T-cell Lymphoma

300 Non-hodgkin Lymphoma patients (age \>=18y) without previous treatment would be administered, including DLBCLs and PTCLs.

Wei Zhang

Xiao Han

Daobin Zhou, MD

The purpose of this study is to evaluate the effectiveness of circulating DNA from peripheral blood for predicting the prognosis and relapse in DLBCL and PTCL patients.

The investigators plan to prospectively involve 300 Non-hodgkin Lymphoma patients, including both diffuse large B cell lymphomas and peripheral T cell lymphomas without previous treatment from Peking Union Medical College Hospital.

The following parameters were collected: age, sex, subtype, Eastern Cooperative Oncology Group (ECOG) performance status (PS), Ann Arbor stage (I-IV), presence of B symptoms, number and type of involved sites, prognostic index including International Prognostic Index (IPI) for DLBCLand PIT for PTCL based on medical record review.

All patients would have regular treatment and follow up in PUMCH. During the follow up, treatment response was evaluated by contrast enhanced computed tomography or PET-CT.

The peripheral blood would be collected and circulating DNA would be tested at the time of diagnosis, interim of treatment, end of treatment, 1 year follow-up, 1.5 year of follow-up, 2 year of follow up, 3 year of follow-up and disease progression or relapse. TCR/BCR domain would be sequenced by high-throughput sequencing.

Effectiveness of Circulating DNA for Predicting the Relapse and Overall Survival in NHL Patients

Effectiveness of Circulating DNA for Predicting the Relapse and Overall Survival in Non-hodgkin Lymphoma Patients

Peking Union Medical College Hospital

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Sarcoma

Neoplasms, Glandular and Epithelial

Neoplasms, Connective and Soft Tissue

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Durvalumab

Trabectedin

Antineoplastic Agents, Immunological

Antineoplastic Agents, Alkylating

Alkylating Agents

Trabectedin will be administered intraveinously, on day 1 of each cycle, every three weeks, as appropriate for assigned dose level.

Durvalumab will be administered intraveinously, at fixed doses of 1120 mg (equivalent to 15 mg/kg), on day 2 of each cycle, every three weeks.

Dose Escalation : 3 doses of trabectedin given in combination with durvalumab (fixed dose) will be investigated.

A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.).

Expansion cohorts: Once the Maximum Tolerated Dose (MTD) has been defined, the expansion cohorts will be opened. All patients will be treated at the MTD of Trabectedin (as defined in the dose escalation part of the trial) given in association with Durvalumab with the same schedule as in the dose escalation part of the trial.

Combination of trabectedin with durvalumab

A phase Ib trial study of trabectedin when prescribed in combination with durvalumab in locally advanced/unresectable soft-tissue sarcoma and ovarian carcinomas.

This is a multicenter, prospective phase Ib trial based on a dose escalation study design (3+3 traditional design) assessing three dose levels of Trabectedin given with durvalumab, followed by two expansion cohorts once the MTD is established.

This is a multicenter, prospective open-labeled phase Ib trial based on a dose escalation study design (3+3 traditional design) assessing three dose levels of trabectedin when prescribed in combination with durvalumab followed by two expansion cohorts (Soft-tissue sarcomas and ovarian carcinomas) once the MTD is established

Trabectedin Combined With Durvalumab in Patients With Advanced Pretreated Soft-tissue Sarcomas and Ovarian Carcinomas.

Trabectedin Combined With Durvalumab (MEDI4736) in Patients With Advanced Pretreated Soft-tissue Sarcomas and Ovarian Carcinomas. A Phase Ib Study.

Identification of predictive signature in responders by sequencing tumor sample

AstraZeneca

PharmaMar

Institut Bergonié

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Herbal and Botanical

Cola

Moderate intensity physical effort and meal (once)

Low intensity physical effort and meal (visit 1, day of cycle 1 chemotherapy) and low intensity physical effort (visit 2, day of cycle 2 chemotherapy)

Pedaling 15 minutes at 75 Watt then 100 Watt of the ergometer

Moderate intensity physical effort

Pedaling 3 minutes at the 30 Watt level of the ergometer

Low intensity physical effort

Eating an hyperlipidic meal 60 minutes after a physical effort

Hyperlipidic meal

Multiple measure of circulating DNA: on an empty stomach, at the end of the physical effort, after 15, 30 and 60 minutes of rest, 120 minutes after an hyperlipidic meal.

An additional measure will occur for subjects free of malignancy during the effort.

Measure of circulating DNA

Annie BERGERA

Pierre LAURENT-PUIG, MD-PHD

Pierre LAURENT-PUIG, MD-PhD

The study of circulating tumoral DNA makes it possible to study, without invasive procedures or pathological studies, the tumoral DNA circulating in the blood of a patient and its various alterations. In patients with colon-rectal cancer with resected tumor, circulating tumor DNA can be used as a predictive biomarker of metastatic relapse of cancer. However, the routine extension of circulating tumoral DNA remains limited due to several difficulties. One of the pifalls that circulating tumor DNA is greatly diluted by healthy circulating DNA from non-tumor cells. The amount of healthy circulating DNA has been described as being influenced by certain physiological parameters. The aim of the study is to increase knowledge on the influence of physiological factors associated with sports activity and meal on the release kinetics of circulating DNA.

20 subjects free of malignancy (Male-Female Ratio 2 to 1) the variation in the concentration of DNA circulating between the value measured on an empty stomach after 1 hour of rest, then at the end of each of the successive stages of moderate intensity physical effort: pedaling 15 minutes at 75 Watt then 100 Watt of the ergometer. Dosages will be repeated after 15, 30 and 60 minutes of recovery. After an hour of recovery, the subject will be asked to consume a meal rich in fat. The circulating DNA will be measured 2 hours after the end of the meal.

40 patients with colon cancer will be enrolled for a two visit study. The first visit will be planned at the first cycle of chemotherapy, before the chemotherapy. At this visit, the influence of exercise on plasma concentrations of circulating free DNA will also be studied in 40 patients with colon cancer. Free circulating DNA will be measured on an empty stomach after 1 hour of rest, then immediately after low-intensity physical effort : pedaling 3 minutes at the 30 Watt level of the ergometer) and after 15, 30 and 60 minutes of recovery. After an hour of recovery, the subject will be proposed to consume a meal rich in fat. The circulating DNA will be measured 2 hours after the end of the meal. The second visit will be planned at the first second of chemotherapy, before the chemotherapy. Free circulating DNA will be measured on an empty stomach after 1 hour of rest, then immediately after low-intensity physical effort : pedaling 3 min at the 30 Watt level of the ergometer, and after 15, 30 and 60 minutes of recovery.

Impact of Exercise and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects

Impact of Sport Practice and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects. Physiological Pilot Study

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Variation in the concentration of circulating DNA between the value measured after 1 hour of rest, during and at recovery of moderate intensity physical effort

Variation in the concentration of circulating DNA between the value measured before and after an hyperlipidic meal in subjects free of malignancy

Variation in the concentration of circulating DNA between the value measured after 1 hour of rest, during and at recovery of low intensity physical effort

Variation in the concentration of circulating DNA between the value measured before and after an hyperlipidic meal

Eurofins Biomnis

Assistance Publique - Hôpitaux de Paris

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Neoplasm Metastasis

Neoplastic Cells, Circulating

Rectal Neoplasms

Lung Neoplasms

Rectal Diseases

Neoplastic Processes

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Each patient is treated with 2 RFA interventions.

Each patient is treated with 2 RFA interventions. Abiopsy of one metastasis is done at each RF session. Histological samples are sent to the Bio-pathology department of Institut Bergonié for tumor infiltrating lymphocytes counting. Primary outcome results from this counting (stromal TILs ≥ 20% is considered as a significant level, a comparative measurement before and after RF will be performed). In parallel blood samples are performed before and after RFA to analyze the kinetics of peripheral blood T lymphocytes subsets, tumoral circulating cells and tumoral DNA.

RFA interventions

Local percutaneous thermal ablation is frequently proposed in the management of metastatic diseases. Radiofrequency ablation (RFA) has demonstrated good results when the metastatic disease is limited and slowly evolving. The destruction of solid metastasis by RF leads to inflammatory and immunological mechanisms that remain poorly understood. These pathological events may influence the overall and anti-tumor host immune responses. The purpose of the study is to identify and quantify some immune mechanisms triggered by RFA of pulmonary metastases from colorectal cancer origin.

RFA could provide activatory signals and become a source of tumor antigens for the immune system. Generating a massive and transient release of antigens, RFA could boost lymphocyte proliferation and production of inflammatory cytokines in response to tumor extracts. Herein, the investigator aims to demonstrate that RFA can amplify the specific T cell response in metastatic cancer patients. In order to ensure this, he plans to assess and quantify tumor infiltrating lymphocytes through tumoral biopsies. He also plans to measure the CD4, CD8 and NK lymphocytes release, the circulating DNA and tumoral cells release, during RFA of lung metastases. On tumoral biopsies, the expression of PDL-1 ligand will also be evaluated and measured. Participants with bilateral metastases or with 5 or more unilateral metastases will be recruited. The two RFA interventions will be carried out within 4-6 weeks of each other. Blood samples and tumoral biopsies will be performed during each intervention. Biopsies will be performed on a metastasis before the thermal ablation. Blood samples will be performed just before RFA, 30 min after RFA and one day after. Analysis, identification and measure of lymphocytes release will be performed with flow cytometry. All analysis and measurements will be performed in the Bio-Pathology department of Institut Bergonié.

Immune Mechanisms After Radiofrequency Ablation of Pulmonary Metastases From Colorectal Cancer Origin

Immune Mechanisms After Radiofrequency Ablation of Pulmonary Metastases From Colorectal Cancer Origin- ARFIM Study

Groupement Interrégional de Recherche Clinique et d'Innovation

Infections

Carcinoma, Hepatocellular

Hepatitis A

Hepatitis

Hepatitis B

Virus Diseases

Neoplasm, Residual

Adenocarcinoma

Liver Neoplasms

Liver Diseases

Herpes Simiae (B Virus)

Pei-Jer Chen, MD-PhD

Shiou-Hwei Yeh, Ph.D.

Pei-Jer Chen, MD/PhD

Shiou-Hwei Yeh, PhD

Early stage HCC is treated by curative surgical resection or by local ablation (such as radio-frequency) as the current standard of care. The complete removal of clinical visible HCC is then confirmed by imaging by MRI or CT, or by a decline of tumor marker (AFP or PIVKA). However, despite an apparent complete removal of the HCC, those post-curative patients frequently develop tumor recurrence at a rate ranging 10-50% within the first year. The high rate of early HCC recurrence indicated a minimal residual HCC after the curative therapies in a significant proportion of patients. A better and more specific biomarker for detecting the residual HCC will improve the patients' prognosis prediction and therapeutic plan.

To detect the minimal residual HCC, a biomarker unique to the tumor is needed. Currently, the cell-free circulating DNA carrying tumor-specific somatic mutations has been advocated as a promising one. It has been applied to investigate the tumor responses or resistances to cancer therapy. However, currently it is restricted to detect or follow only large advanced cancer, because of the difficulty in separating or enriching the cfDNA with tumor-specific mutations from the cfDNA from normal cells. In this project, the investigators proposed that one class of somatic mutation in HBV-related HCC, namely the insertion mutagenesis by integrated HBV DNA, could be adopted to circumvent this difficulty. HBV DNA integration has been found in the chromosomes of about 90% of HBV-related HCC and the integration site is unique to individual HCC. The HBV-host junction DNA fragment from one HCC is therefore a tumor-specific biomarker. Such fragments can be released into the circulation as cell-free circulating DNAs, and the detection of the HBV-host chimera DNAs in the circulation is a reliable evidence for the presence of the tumor in the patient. Therefore the cf circulating HBV-host chimera DNA is proposed to assay any minimal residual HCC after curative therapies.

Development stages:

Stage I: Identification of integrated HBV DNA sites in HBV-related HCC tissues. the investigators will develop either HBV-specific inverse PCRs or capture-sequencing protocols to identify HBV integrations sites in the tumor chromosomes. The viral-host junction sequences of individual HCC identified and used as the template for developing assays for detecting the same HBV-host chimera DNA fragment in the circulation.

Stage II: New platforms to accurately detect or even quantitate the circulating vh-chimera DNA fragment.

These tumor-specific vh-chimera DNA will only represent a tiny fraction of total cfDNAs. However, as these sequences of the tumor-specific vh-chimera DNA have been known from stage 1, the investigators may develop better and more specific assays for quantitation.

Stage III: Assays for cell-free tumor specific vh-chimera DNA applied to the blood samples from post-curative HCC patients.

To demonstrate the efficacy of these assays, blood samples obtained at 4 weeks after curative therapies from 50 HBV-related HCC patients, and tested for the presence of cf tumor-specific vh-chimera DNAs. The presence or absence of such vh-chimera DNA will be correlated with the early HCC recurrence within the first year to determine any clinical significance. There will be one blood sampling at the time of HCC recurrence.

Sample collection In stage I and II, the investigators will set up methods for chimera DNA identification and quantification, which need tumor samples to support the development and evaluation of the feasibility for each assay. Therefore, the investigators will apply the approval for use the tissues from the Taiwan Liver Cancer Network (TLCN), including 20 pairs of HBV-related male HCC, 20 pairs of HBV-related female HCC (for positive control), 20 pairs of HCV related male HCC, 20 pairs of HCV related female HCC (for negative control), 20 pairs of HBV- and HCV-related male HCC, and 20 pairs of HBV- and HCV-related female HCC (to see if vh-chimera DNA is also applicable for HBV- and HCV-related HCC). Both the genomic DNA and RNA will be applied for these 120 patients in total. Genomic DNA will be used in assay development, including identification, detection and quantification; whereas RNA will be used in validation of the insertional mutagenic RNA transcripts, which will provide supporting evidence for tumor specific integration from transcription level.

In stage III, the investigators will investigate whether there is any correlation between tumor-specific vh-chimera DNA level and recurrence-free survival using the assays the investigators developed in stage I and II. Therefore, the investigators will collect the Tumor (T) and non-Tumor (NT) tissue pairs from 50 HBV-related HCC patients that receive surgical removal of tumor, and also the peripheral blood at 4w after surgery. T and NT tissues are for vh-chimera DNA identification, peripheral blood will be used for vh-chimera DNA detection and quantification. On the other hand, clinical information including tumor size, tumor grade, serum markers from routine liver function test (ALT, AST), current HCC marker (AFP), and recurrence-free survival time will be collected for correlation study. All data will be stored in computer with password protection.

Tumor (T) and non-Tumor (NT) tissue, and peripheral blood.

HBV-host cfDNA as Minimal Residual Tumor Marker for HBV-related HCC

A New Biomarker for Detection of Minimal Residual Tumor in Hepatitis-B Virus Related Hepatocellular Carcinoma After Curative Therapies: The Cell-free Circulating HBV-host Chimera DNA Fragment

Detection of the HBV-host chimera DNA in blood sample.----- one blood sampling at the time of HCC recurrence.

clinical information about HCC recurrence. detection by CT or MRI.

clinical information about HCC recurrence.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effectiveness of Circulating DNA for Predicting the Relapse and Overall Survival in NHL Patients	NCT03079947	Diffuse Large B... Peripheral T Ce...		18 Years - 80 Years	Peking Union Medical College Hospital
Trabectedin Combined With Durvalumab in Patients With Advanced Pretreated Soft-tissue Sarcomas and Ovarian Carcinomas.	NCT03085225	Ovarian Carcino... Soft Tissue Sar...	Combination of ...	18 Years -	Institut Bergonié
Impact of Exercise and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects	NCT05147545	Colon Cancer	Moderate intens... Low intensity p... Hyperlipidic me... Measure of circ...	18 Years - 85 Years	Assistance Publique - Hôpitaux de Paris
Trabectedin Combined With Durvalumab in Patients With Advanced Pretreated Soft-tissue Sarcomas and Ovarian Carcinomas.	NCT03085225	Ovarian Carcino... Soft Tissue Sar...	Combination of ...	18 Years -	Institut Bergonié
Immune Mechanisms After Radiofrequency Ablation of Pulmonary Metastases From Colorectal Cancer Origin	NCT03960021	Immune Evasion,... Neoplastic Cell... Circulating Tum... Pulmonary Metas... Colo-rectal Can...	RFA interventio...	18 Years -	Institut Bergonié
HBV-host cfDNA as Minimal Residual Tumor Marker for HBV-related HCC	NCT03020342	Carcinoma, Hepa...		20 Years -	National Taiwan University Hospital

Spots Global Cancer Trial Database for circulating dna