NCT01198743

Brief Summary

Cancer is a DNA disease characterized by the presence of genetics alterations in cancer cells. The recent studies underline that these recurring alterations must be considered as a good molecular marker. In fact, they could use for tumor DNA detection in different biological fluids. So, the main purpose is to define the presence of circulating tumor DNA in the patients plasma with colorectal cancer, by the presence of mutation (KRAS, NRAS, BRAF, APC, TP53 and MIRCOSATELLIE instability). These molecular analysis will be done both in tumor and plasma samples, This trial allows to characterize the prognostic value of circulating tumoral DNA presence in colorectal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
261

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2005

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

Study Start

First participant enrolled

November 1, 2005

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 10, 2010

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

11.5 years

First QC Date

June 2, 2010

Last Update Submit

August 28, 2017

Conditions

Colorectal Neoplasms

Keywords

Genetics modificationscolorectal cancerprognosis aimDNAPlasma

Outcome Measures

Primary Outcomes (1)

  • local recidivism or metastasis reappearance

    6 months after operation

Secondary Outcomes (1)

  • specificity and global safety

    36 monhs after operation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

defined population : patients suffer from colorectal cancers in stage II-III

You may qualify if:

  • patients aged Superior to 18 and inferior to 85
  • Colon or rectal cancer stage II and III should be surgically treated
  • informed consent signed

You may not qualify if:

  • patients suffered from synchronous metastasis disease in initial cancer diagnosis
  • patients with 2 synchronous colorectal cancers
  • receiving chemotherapy or radiotherapy, before operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HEGP

Paris, 75015, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum and tissue

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Pierre LAURENT-PUIG

    HEGP/ Paris Descartes University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 2, 2010

First Posted

September 10, 2010

Study Start

November 1, 2005

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

August 29, 2017

Record last verified: 2017-08

Locations

FR(1)