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CancerDOCCNCT01057953

Oligogenic Determinism of Colorectal Cancer

A study testing Blood drawn in people with Cancer, run by University Hospital, Rouen at 16 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The majority of the clinical situations suggestive of an increased genetic risk for colorectal cancer (CRC) are not explained by a simple monogenic model. Our working hypothesis is that a fraction of clinical conditions suggestive of an increased genetic risk for CRC (familial aggregation, early age of tumour onset… Read more about this study

Who is it for?
Ages 18 to 61 yearsHealthy volunteers can take part
Conditions the study is for
Cancer
What is being tested?
Blood drawn
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,550 participants
Where
16 sitesFrance
Study dates
Jan 2010to Jan 2013
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 61 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • colorectal cancer (CRC) in two first degree relatives, one being diagnosed before 61 years of age
  • CRC diagnosed before 51 years of age or advanced colorectal adenoma before 41 years of age
  • multiple primary CRCs in the same individual, the first being diagnosed before 61 years of age.

Who cannot join

  • Lynch syndrome,
  • adenomatous polyposis defined by more than 10 adenomas histologically proved,
  • hamartomatous polyposis defined by one hamartoma histologically proved,
  • absence of informed consent.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

France16 sites
  • Centre François Baclesse

    Caen, 14000

  • CHU de Dijon

    Dijon

  • CHU de Grenoble

    Grenoble

  • CHRU de Lille

    Lille

  • CHU de Montpellier

    Montpellier

  • CLCC Val d'Aurelle

    Montpellier

  • CH de Niort

    Niort

  • Institut Curie

    Paris, 75005

  • Hôpital Européen Georges Pompidou

    Paris

  • Centre Eugène Marquis

    Rennes, 35000

  • CHU de Rennes

    Rennes

  • UHRouen

    Rouen, 76031

  • CHU de Saint-Etienne

    Saint-Etienne

  • CHU de Toulouse

    Toulouse

  • Institut Claudius Regaud

    Toulouse

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

About this study

The majority of the clinical situations suggestive of an increased genetic risk for colorectal cancer (CRC) are not explained by a simple monogenic model. Our working hypothesis is that a fraction of clinical conditions suggestive of an increased genetic risk for CRC (familial aggregation, early age of tumour onset, development of multiple primary CRC) is due to the combination of a limited number of genetic variations, each conferring a moderate risk for CRC, but whose combination results into high risk.

This study, which will be both retrospective and prospective, is an association study that will compare frequencies of selected genetic variations, alone or in combination, between patients (cases) whose clinical presentation is suggestive of an increased genetic risk but who do not present a known Mendelian form of CRC, and controls, in order to assess associations of these variations with non-Mendelian genetic forms of CRC. The inclusion criteria will be: CRC in two first degree relatives, one being diagnosed before 61 years of age; or CRC diagnosed before 51 years of age or advanced colorectal adenoma before 41 years of age; or multiple primary CRCs in the same individual, the first being diagnosed before 61 years of age The exclusion criteria will be: Lynch syndrome, adenomatous polyposis and hamartomatous polyposis. The genetic variations which will be analyzed will include (i) SNPs detected by GWAS and associated to CRC. (ii) Risk factors corresponding to functional polymorphisms within candidate genes. (iii) Imbalance of the TGFbR1 allelic expression. Sample sizes were calculated to obtain 80% power for an odds ratio of 2.5 since the aim of this study is to determine genetic variations conferring a moderate risk. In order to cover all these possibilities and to have reasonable even for the genetic variations with low frequency below 0.03 or high frequency above 0.90, the target sample size was set at 700 cases and 350 controls. The recruitment of patients will be performed at the national level by the cancer genetics departments ensuring a correct evaluation of the personal and familial history and the French molecular diagnosis laboratories network ensuring in routine the analysis of the main genes involved in CRC. The control population will be composed of healthy subjects of Caucasian origin between 45 and 60 years of age, without personal or familial history among their first-degree relatives of colorectal tumours.

Demonstration that the combination of a limited number of genetic variations, each conferring a moderate risk for CRC, results into high risk would allow to base, in selected families, the evaluation of risk in relatives and indication of colonoscopy on the analysis of gene variants the combination of which would confer a high risk. This study will confirm or invalidate the contribution of aTGFbR1 allelic expression imbalance in the determinism of early-onset CRC and familial aggregation of CRC. The demonstration of the involvement in CRC genetic variations with strong effect of specific combinations should be of interest for our general understanding of the molecular basis of CRC.

Conditions
Cancer
Being tested
Blood drawn
Keywords
Colo-Rectal Cancer
Medical subject headings
Neoplasms, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood drawnGenetic

    Blood drawn for patient

Study groups in NCT01057953
Study groupRoleWhat they receive
PatientNo interventionBlood sample for patient included
Receives: Genetic: Blood drawn

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. genetic variation assessment

    Measured: once

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

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
1,550 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01057953
Sponsor's protocol ID
2009/082/HP
Acronym
DOCC
Status last verified
Apr 2026
First submitted
27 Jan 2010
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Baert-Desurmont S, Charbonnier F, Houivet E, Ippolito L, Mauillon J, Bougeard M, Abadie C, Malka D, Duffour J, Desseigne F, Colas C, Pujol P, Lejeune S, Dugast C, Buecher B, Faivre L, Leroux D, Gesta P, Coupier I, Guimbaud R, Berthet P, Manouvrier S, Cauchin E, Prieur F, Laurent-Puig P, Lebrun M, Jonveaux P, Chiesa J, Caron O, Morin-Meschin ME, Polycarpe-Osaer F, Giraud S, Zaanan A, Bonnet D, Mansuy L, Bonadona V, El Chehadeh S, Duhoux F, Gauthier-Villars M, Saurin JC, Collonge-Rame MA, Brugieres L, Wang Q, Bressac-de Paillerets B, Rey JM, Toulas C, Buisine MP, Bronner M, Sokolowska J, Hardouin A, Cailleux AF, Sebaoui H, Blot J, Tinat J, Benichou J, Frebourg T. Clinical relevance of 8q23, 15q13 and 18q21 SNP genotyping to evaluate colorectal cancer risk. Eur J Hum Genet. 2016 Jan;24(1):99-105. doi: 10.1038/ejhg.2015.72. Epub 2015 Apr 15.

    PubMed 25873010

Questions about this trial

What is this clinical trial studying?

A study testing Blood drawn in people with Cancer, run by University Hospital, Rouen at 16 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. 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 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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?

genetic variation assessment (time frame: once). 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 NCT01057953, 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 16 Apr 2026.

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