NCT01577511

Brief Summary

The main objective of this study is to identify and characterize subpopulations of cells with invasive capacity in colorectal cancer from primary tumor, blood and metastatic samples.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2012

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

April 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

June 12, 2012

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

November 19, 2025

Status Verified

January 1, 2020

Enrollment Period

4.6 years

First QC Date

April 12, 2012

Last Update Submit

November 17, 2025

Conditions

Keywords

invasive potentialmolecular characterisation of circulating cells

Outcome Measures

Primary Outcomes (1)

  • Ability to maintain the cells isolated from colorectal tumors in culture or 3D collagen matrices and then infect these cells to make them express reporter genes: yes/no.

    Baseline (Day 0)

Secondary Outcomes (21)

  • Serology HIV

    baseline; day 0

  • Serology Hepatitis B

    baseline; day 0

  • Serology Hepatitis C

    baseline; day 0

  • Location of primary tumor

    base line; day 0

  • Age at diagnosis

    baseline, day 0

  • +16 more secondary outcomes

Study Arms (1)

30 Patients

Patients with operable, stage III or IV, adenocarcino-type colorectal cancer treated at the Nîmes University Hospital. Intervention: Samples and follow up

Biological: Samples and follow up

Interventions

Samples: Peroperative blood sample plus primary and metastatic tumor biopsies. Follow-up: disease outcomes assessed at 24 months

30 Patients

Eligibility Criteria

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

Patients with operable, stage III or IV, adenocarcino-type colorectal cancer treated at the Nîmes University Hospital.

You may qualify if:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • Patient with adenocarcinoma-type colorectal cancer:
  • stage III at diagnosis, surgical resection of the primary tumor proposed.
  • stage IV at diagnosis, surgical resection of the primary tumor and possibly of metastases proposed.
  • Stage IV who have already undergone surgical excision of the primary tumor, and for whom metastasectomy is now proposed.

You may not qualify if:

  • The patient is participating in another study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • Patients for whom surgical resection of the primary tumor is not considered as an option
  • PStage IV at diagnosis, but metastasectomy is not considered as an option
  • Patients with positive HIV, Hepatitis B or Hepatitis C serology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

Location

Related Publications (1)

  • Grillet F, Bayet E, Villeronce O, Zappia L, Lagerqvist EL, Lunke S, Charafe-Jauffret E, Pham K, Molck C, Rolland N, Bourgaux JF, Prudhomme M, Philippe C, Bravo S, Boyer JC, Canterel-Thouennon L, Taylor GR, Hsu A, Pascussi JM, Hollande F, Pannequin J. Circulating tumour cells from patients with colorectal cancer have cancer stem cell hallmarks in ex vivo culture. Gut. 2017 Oct;66(10):1802-1810. doi: 10.1136/gutjnl-2016-311447. Epub 2016 Jul 25.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peroperative blood sample plus primary and metastatic tumor biopsies.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jean-François Bourgaux, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 12, 2012

First Posted

April 16, 2012

Study Start

June 12, 2012

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

November 19, 2025

Record last verified: 2020-01

Locations