Colorectal CancerNCT00055848
Genetic Study of Familial Factors in Patients With Colon Cancer
An observational study of Colorectal Cancer, run by Alliance for Clinical Trials in Oncology at 1 site in United States.
Trial summary
RATIONALE: Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer. PURPOSE: Clinical trial to study the cancer-related genes in patients who have colon cancer or adenomatous polyps. Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- cytogenetic analysis, gene mapping and microarray analysis
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2001to Oct 2010
- Phase
- Observational
- 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with colon cancer or polyps age 70 or under. Specifically, patients previously enrolled on CLB-9581, CLB-89803 and CLB-80001.
DISEASE CHARACTERISTICS:
- Diagnosis of colon cancer or polyps at age 70 or under
- Has a living full sibling with diagnosis of colon cancer or polyps at age 70 or under
- No history of familial adenomatous polyposis syndrome
- No hereditary nonpolyposis colon cancer, according to Amsterdam criteria
- No known I1370K adenomatous polyposis of the colon susceptibility variant
- Enrolled on 1 of the following clinical trials:
- CLB-9581
- CLB-89803
- CLB-80001 NOTE: Patients do not need to be receiving protocol therapy. Patients who are outside the treatment protocol's follow-up range are eligible. Patients who discontinued therapy for any reason, including toxic effects, are eligible.
PATIENT CHARACTERISTICS:
Age
- 70 and under at diagnosis
Other
- No significant psychiatric illness that would preclude giving informed consent
- No inflammatory bowel disease (in patient or sibling)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534
About this study
Official title: Familial Factors in the Development of Colon Cancer
RATIONALE: Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer.
PURPOSE: Clinical trial to study the cancer-related genes in patients who have colon cancer or adenomatous polyps.
Read the detailed description
OBJECTIVES:
- Identify human colon neoplasia susceptibility genes in patients with colon cancer or adenomatous polyps.
- Correlate the inheritance of novel susceptibility alleles for adenomatous polyposis of the colon with colon neoplasia in these patients.
- Correlate colon neoplasia susceptibility with the presence of COX-2, sPLA2, and DNMT genes in these patients.
- Identify a novel gene that governs increased susceptibility to colon adenoma and cancer in the genome of these patients.
- Conditions
- Colorectal Cancer
- Being tested
- cytogenetic analysis, gene mapping, microarray analysis
- Keywords
- adenocarcinoma of the colon, stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytogenetic analysisGenetic
gene mappingGenetic
microarray analysisGenetic
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients donate blood samples for analysis of colorectal susceptibility genes. Patients also complete a questionnaire regarding family cancer history.
A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute.
Participants do not receive the results of the genetic testing, and the results do not influence the type or duration of treatment. Receives: Genetic: cytogenetic analysis; Genetic: gene mapping; Genetic: microarray analysis |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2003 (estimated)
- Study startDec 2001
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Monica M. Bertagnolli, MD, Study chair, Dana-Farber/Brigham and Women's Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00055848
- Sponsor's protocol ID
- CALGB-150008
- Other IDs
- CALGB-150008, CDR0000271314
- Status last verified
- Jul 2015
- First submitted
- 6 Mar 2003
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Familial Factors in the Development of Colon Cancer
- ClinicalTrials.gov ID
- NCT00055848
- Acronym / sponsor ID
- CALGB-150008
- Conditions
- Colorectal Cancer
- Keywords
- adenocarcinoma of the colon, stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2001
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 7 Mar 2003 (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: Genetic studies may help in understanding the genetic processes involved in the development of some types of cancer.
PURPOSE: Clinical trial to study the cancer-related genes in patients who have colon cancer or adenomatous polyps.
Detailed description
OBJECTIVES:
- Identify human colon neoplasia susceptibility genes in patients with colon cancer or adenomatous polyps.
- Correlate the inheritance of novel susceptibility alleles for adenomatous polyposis of the colon with colon neoplasia in these patients.
- Correlate colon neoplasia susceptibility with the presence of COX-2, sPLA2, and DNMT genes in these patients.
- Identify a novel gene that governs increased susceptibility to colon adenoma and cancer in the genome of these patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Genetic: cytogenetic analysis, Genetic: gene mapping, Genetic: microarray analysisPatients donate blood samples for analysis of colorectal susceptibility genes. Patients also complete a questionnaire regarding family cancer history. A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute. Participants do not receive the results of the genetic testing, and the results do not influence the type or duration of treatment. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with colon cancer or polyps age 70 or under. Specifically, patients previously enrolled on CLB-9581, CLB-89803 and CLB-80001.
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 |
|---|---|---|
| cytogenetic analysis | Genetic | Group 1 |
| gene mapping | Genetic | Group 1 |
| microarray analysis | Genetic | Group 1 |
Primary outcome
Not reported in the source record.
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 13 Jul 2016.
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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.
Monica M. Bertagnolli, MD study chair
Dana-Farber/Brigham and Women's Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Alliance for Clinical Trials in Oncology at 1 site in United States.
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 13 Jul 2016. 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 United States. 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.
Where can I read the original study information?
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 13 Jul 2016.