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

Metastatic Cancer Clinical Trial

— Epitopes-CRC01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02838381
• Other study ID #: P/2011/117
• Status: Recruiting
• Phase: N/A
• Start date: June 2012
• Est. completion date: December 2022

Study information

• Verified date: May 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Christophe Borg, Pr
• Email: christophe.borg[@]efs.sante.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary

Intervention

Other:
• Additional biological samples
blood and tissue samples

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Besançon	Besançon
France	Hôpital Nord Franche Comté	Montbéliard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of peripheral T cell immune responses in the presence of antigenic peptides associated with digestive cancer		at inclusion
Primary	progression-free survival	time interval between the date of inclusion and the date of first progression or death from any cause.	within 5 years after the inclusion