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CompletedNCT02838381Epitopes-CRC01Updated Dec 27, 2024

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

An interventional study of Additional biological samples in Metastatic Cancer, sponsored by Centre Hospitalier Universitaire de Besancon. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
553
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 553 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
553 participants (actual)

Study arms

  • 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

Interventions

  • OtherAdditional biological samples

    blood and tissue samples

06

What researchers measure

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

    Time frame: within 5 years after the inclusion

07

Study locations

2 sites
  • Centre Hospitalier Universitaire de Besançon
    Besançon, France
  • Hôpital Nord Franche Comté
    Montbéliard, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02838381
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
Jul 20, 2016
Start date
Jun 2012
Primary completion
Dec 31, 2023
Completion
Jun 11, 2024
Last update
Dec 27, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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