Study of Genetic and Cellular Immunological Parameters Predictive of Disease-free Survival in Patients With Metastatic Cancer (Epitopes-CRC01)

Centre Hospitalier Universitaire de Besancon

Status: Unknown

Conditions: Metastatic Cancer

Treatments: Other: Additional biological samples

Study type: Interventional

Funder types: Other

Identifiers

NCT02838381

P/2011/117

Details and patient eligibility

About

The aim of this study is to characterize the genetic and cellular immunological parameters of metastatic digestive cancer patients having short and long responses to chemotherapy.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

For all patients:

• signed written informed consent

For cohort A:

• patient with metastatic colorectal cancer with first-line therapy by chemotherapy +/- surgery and with a disease-free survival > or = at 20 months
• Ct-scan realized in the previous 4 weeks and showing no progression according to the Recist criteria v1.1

For cohort B:

• patient treated for metastatic colorectal cancer and chemotherapy responder (obtention of an objective response according to the Recist criteria V1.1 in first-line therapy), with a disease-free survival < 10 months (disease progression must be confirmed by CT scan evaluation according to Recist v1.1 criteria)

For cohort C:

• patients with no metastatic rectum cancer in complete remission after chemotherapy and/or radiotherapy

For cohort D:

• patients with metastatic or locally advanced cancer in complete remission after treatment, non eligible in the other cohorts

Exclusion criteria

For all patients:

• patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study
• patient with a neurodegenerative disease
• patient under guardianship, curator or under the protection of justice

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

300 participants in 1 patient group

Additional biological samples

Other group

Description:

Additional blood samples will be realized at the inclusion of patients. Two optional blood samples could be realized if necessary with at least 3 months apart. Peripheral Blood Mononuclear Cells (PBMC) will be collected. Tissue tumor will be collected if available.

Treatment:

Other: Additional biological samples