Colorectal CancerNCT00628368
Biological Factors in Predicting Response to Treatment in Patients With Esophageal Cancer or Rectal Cancer
A study testing Gene expression analysis in people with Colorectal Cancer and Esophageal Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Colorectal Cancer, Esophageal Cancer
- What is being tested?
- Gene expression analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2005to 30 Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
About this study
Official title: Study to Analyze the Predictive Role of Factors Implicated in the Signaling Pathway of the EGFR in Response to Treatment With Neoadjuvant Chemoradiotherapy in Patients With Cancer of the Esophagus or Rectum
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.
Read the detailed description
OBJECTIVES:
Primary
- Analyze various biological factors that can be used as markers to predict response to treatment and correlate with the signaling pathway of EGFR.
Secondary
- Establish a tissue bank to store information about the response to treatment and survival.
OUTLINE: Patients undergo endoscopy, 11 biopsies of tumor tissue, and 3 biopsies of healthy mucosa. Blood samples are also collected. Samples are analyzed for the expression of 4 receptors in the EGFR family, polymorphisms at intron 1 of the EGFR gene, and gene mutations in downstream signaling pathways.
After surgery, patients are followed every 3 months.
- Conditions
- Colorectal Cancer, Esophageal Cancer
- Being tested
- Gene expression analysis
- Keywords
- adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, adenocarcinoma of the rectum, recurrent rectal cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer, recurrent esophageal cancer, stage I esophageal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer
- Medical subject headings
- Colorectal Neoplasms, Esophageal Neoplasms, Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: Gene expression analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of predictive factors in the EGFR signaling pathway in response to treatment
Measured: End of study : approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startNov 2005
- Primary completionSep 2009
- Study completion30 Sep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Ychou, MD, PhD, Study chair, Institut du Cancer de Montpellier - Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628368
- Sponsor's protocol ID
- CDR0000574175
- Other IDs
- CLCC-EGFR-BIO, INCA-RECF0366
- Status last verified
- Feb 2026
- First submitted
- 1 Mar 2008
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28212429
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Analyze the Predictive Role of Factors Implicated in the Signaling Pathway of the EGFR in Response to Treatment With Neoadjuvant Chemoradiotherapy in Patients With Cancer of the Esophagus or Rectum
- ClinicalTrials.gov ID
- NCT00628368
- Acronym / sponsor ID
- CDR0000574175
- Conditions
- Colorectal Cancer, Esophageal Cancer
- Keywords
- adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, adenocarcinoma of the rectum, recurrent rectal cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- Nov 2005 (actual)
- Primary completion
- Sep 2009 (actual)
- Study completion
- 30 Sep 2009 (actual)
- First posted
- 5 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary
- Analyze various biological factors that can be used as markers to predict response to treatment and correlate with the signaling pathway of EGFR.
Secondary
- Establish a tissue bank to store information about the response to treatment and survival.
OUTLINE: Patients undergo endoscopy, 11 biopsies of tumor tissue, and 3 biopsies of healthy mucosa. Blood samples are also collected. Samples are analyzed for the expression of 4 receptors in the EGFR family, polymorphisms at intron 1 of the EGFR gene, and gene mutations in downstream signaling pathways.
After surgery, patients are followed every 3 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Rectal and oesophagus cancer | Experimental | Genetic: Gene expression analysisAdditionnal samples from routine care (tumor tissue and healthy tissue and one blood tube) and standardized clinical data will be entered into a database. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gene expression analysisTissue 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. | Genetic | Experimental: Rectal and oesophagus cancer |
Primary outcome
Determination of predictive factors in the EGFR signaling pathway in response to treatment
Time frame: End of study : approximately 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Results publication: PubMed 28212429Arsic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Ychou, MD, PhD study chair
Institut du Cancer de Montpellier - Val d'Aurelle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gene expression analysis in people with Colorectal Cancer and Esophageal Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of predictive factors in the EGFR signaling pathway in response to treatment (time frame: End of study : approximately 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00628368, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.