NCT03015038

Brief Summary

Duration of each part of the study per patient:

  • Screening: From 1 to 4 weeks
  • Sampling period (blood and tissue): 1 day
  • Follow-up by patient: 60 months
  • Total study duration by patient: 84 months
  • Total inclusion duration: 24 months
  • Total Follow-up duration: 60 months
  • Total study duration: 84 months

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

February 5, 2017

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
Last Updated

December 10, 2025

Status Verified

March 1, 2025

Enrollment Period

7 years

First QC Date

December 12, 2016

Last Update Submit

December 3, 2025

Conditions

Colon Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Immune cells trafficking

    Frequency of T cells in the blood and tissue (Flow cytometry method with a panel of Ab).

    Day 0

Secondary Outcomes (2)

  • Infiltration of leucocytes in tumor tissue

    Day 0

  • Safety (Number of adverse events, ECOG status)

    After Day 0 until the end of the study (Month 3, Month 6, Month 9, Month 12, Month 15, Month 18,Month 21, Month 24, Month 30, Month 36, Month 42, Month 48, Month 54 and Month 60)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with colon adenocarcinoma treated by surgery

You may qualify if:

  • Patients aged 18 or more.
  • Affiliation to a social security scheme
  • Diagnosis of a colon adenocarcinoma.
  • Patient have signed and dated consent of the study before undertaking procedures related to the study.

You may not qualify if:

  • Patients under guardianship / curatorship
  • Following Situations
  • Persons unable to understand, read and / or sign an informed consent
  • Patient with the following functions: investigator or co-investigator, research assistant, pharmacist, study coordinator or having any involvement in the study
  • Uncooperative person or potentially non-compliant for the study and its procedures with predictable difficulties regular monitoring of over 1 year.
  • No affiliation to a social security scheme, a universal medical coverage or any similar plan.
  • Pregnant or lactating women.
  • Patients with HIV seropositivity.
  • Rectal tumor location.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Saint Louis

Paris, 75000, France

Location

Related Publications (2)

  • Bonnereau J, Courau T, Asesio N, Salfati D, Bouhidel F, Corte H, Hamoudi S, Hammoudi N, Lavole J, Vivier-Chicoteau J, Chardiny V, Maggiori L, Blery M, Remark R, Bonnafous C, Cattan P, Toubert A, Bhat P, Allez M, Aparicio T, Le Bourhis L. Autologous T cell responses to primary human colorectal cancer spheroids are enhanced by ectonucleotidase inhibition. Gut. 2023 Apr;72(4):699-709. doi: 10.1136/gutjnl-2021-326553. Epub 2022 Jul 8.

    PMID: 35803702RESULT

  • Courau T, Bonnereau J, Chicoteau J, Bottois H, Remark R, Assante Miranda L, Toubert A, Blery M, Aparicio T, Allez M, Le Bourhis L. Cocultures of human colorectal tumor spheroids with immune cells reveal the therapeutic potential of MICA/B and NKG2A targeting for cancer treatment. J Immunother Cancer. 2019 Mar 14;7(1):74. doi: 10.1186/s40425-019-0553-9.

    PMID: 30871626RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Tissu and blood

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Matthieu Allez, MD, PhD

    Hopital Saint Louis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2016

First Posted

January 9, 2017

Study Start

February 5, 2017

Primary Completion

February 5, 2024

Study Completion

February 5, 2024

Last Updated

December 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)