NCT00628368

Brief Summary

RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This clinical trial is studying how well biological factors work in predicting response to treatment in patients with esophageal cancer or rectal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Nov 2005

Typical duration for not_applicable colorectal-cancer

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
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2009

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

3.8 years

First QC Date

March 1, 2008

Last Update Submit

February 6, 2026

Conditions

Colorectal CancerEsophageal Cancer

Keywords

adenocarcinoma of the esophagussquamous cell carcinoma of the esophagusadenocarcinoma of the rectumrecurrent rectal cancerstage I rectal cancerstage II rectal cancerstage III rectal cancerstage IV rectal cancerrecurrent esophageal cancerstage I esophageal cancerstage II esophageal cancerstage III esophageal cancerstage IV esophageal cancer

Outcome Measures

Primary Outcomes (1)

  • Determination of predictive factors in the EGFR signaling pathway in response to treatment

    End of study : approximately 4 years

Study Arms (1)

Experimental: Rectal and oesophagus cancer

EXPERIMENTAL

Additionnal samples from routine care (tumor tissue and healthy tissue and one blood tube) and standardized clinical data will be entered into a database.

Genetic: Gene expression analysis

Interventions

Gene expression analysisGENETIC

Tissue samples (tumor tissue and healthy tissue) frozen and secured in paraffin collected during surgery. One blood tube will be frozen. During a coloscopy or gastroscopy tumor and health tissue samples will be taken for diagnosis and research.

Experimental: Rectal and oesophagus cancer

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or rectum * Planning to receive neoadjuvant treatment, including radiotherapy or chemoradiotherapy PATIENT CHARACTERISTICS: * Not pregnant or nursing * No blood disorder * Not deprived of freedom or protected by law PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Related Publications (1)

  • Arsic N, Ho-Pun-Cheung A, Lopez-Crapez E, Assenat E, Jarlier M, Anguille C, Colard M, Pezet M, Roux P, Gadea G. The p53 isoform delta133p53ss regulates cancer cell apoptosis in a RhoB-dependent manner. PLoS One. 2017 Feb 17;12(2):e0172125. doi: 10.1371/journal.pone.0172125. eCollection 2017.

    PMID: 28212429RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsEsophageal NeoplasmsAdenocarcinoma Of EsophagusEsophageal Squamous Cell CarcinomaRectal Neoplasms

Interventions

Gene Expression Profiling

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesHead and Neck NeoplasmsEsophageal DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative Techniques

Study Officials

  • Marc Ychou, MD, PhD

    Institut du Cancer de Montpellier - Val d'Aurelle

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2008

First Posted

March 5, 2008

Study Start

November 1, 2005

Primary Completion

September 1, 2009

Study Completion

September 30, 2009

Last Updated

February 10, 2026

Record last verified: 2026-02

Locations

FR(1)