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

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Recruiting

CT.gov ID

NCT02838381

Collaborator

(none)

300

Enrollment

Locations

Arm

126

Duration (Months)

150

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Cancer	Other: Additional biological samples	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Jun 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Additional biological samples 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.	Other: Additional biological samples blood and tissue samples

Arm

Intervention/Treatment

Other: Additional biological samples

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.

Other: Additional biological samples

blood and tissue samples

Outcome Measures

Primary Outcome Measures

frequency of peripheral T cell immune responses in the presence of antigenic peptides associated with digestive cancer [at inclusion]
progression-free survival [within 5 years after the inclusion]
time interval between the date of inclusion and the date of first progression or death from any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire de Besançon	Besançon		France
2	Hôpital Nord Franche Comté	Montbéliard		France

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT02838381

Other Study ID Numbers:

P/2011/117

First Posted:

Jul 20, 2016

Last Update Posted:

May 11, 2022

Last Verified:

May 1, 2022

Additional relevant MeSH terms:

Neoplasm Metastasis

Neoplasms

Neoplasms, Second Primary

Study Results

No Results Posted as of May 11, 2022