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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02838381
Acronym
Epitopes-CRC01
Enrollment
553
Registered
2016-07-20
Start date
2012-06-30
Completion date
2024-06-11
Last updated
2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Cancer

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.

Interventions

blood and tissue samples

Sponsors

Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
frequency of peripheral T cell immune responses in the presence of antigenic peptides associated with digestive cancerat inclusion
progression-free survivalwithin 5 years after the inclusiontime interval between the date of inclusion and the date of first progression or death from any cause.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026