Skip to main content
OpenTrials
Completed

NCT Number: NCT02838381

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Besançon, Besançon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Additional biological samples

Other

blood and tissue samples

Primary outcomes

  1. frequency of peripheral T cell immune responses in the presence of antigenic peptides associated with digestive cancer

    Time frame: at inclusion

  2. progression-free survival

    Time frame: within 5 years after the inclusion

    time interval between the date of inclusion and the date of first progression or death from any cause.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: Epitopes-CRC01

Important dates

Study start
2012
Primary completion
2023
Study completion
2024
First posted
Jul 20, 2016
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.