CancerEX²TRICANNCT04141462
EXOME Analysis Position in the Strategy of Genetic Predisposition Factors Identification in Early-onset Cancer
A study testing blood sample in people with Cancer and Genetic Predisposition, run by Centre Georges Francois Leclerc at 6 sites in France.
Trial summary
5 to 10% of cancers are due to the presence of a constitutional genetic alteration. It can be inherited from parents (family form) or by accident, in the first moments of life after fertilization (sporadic form). In both cases, this genetic alteration is constitutional and transmissible to descendants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Genetic Predisposition
- What is being tested?
- blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 613 participants
- Where
- 6 sitesFrance
- Study dates
- 7 Oct 2019to 7 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Index case:
- Major or minor patient
- Histological or cytological evidence of malignant tumor diagnosis
- Patient with cancer before age 40 (or before age 30 for breast cancer).
- Absence of anomaly found on the oncogenetic panel tested in the predisposition concerned
- Patient affiliated to a social security scheme
Show all 15Show fewer
- Signature of Informed Consent EXTRICAN
- Availability of a tumor sample if needed secondary functional studies
- Availability of both parents when the trio approach will be necessary in the population 1 (or validation of the indication in CPR in case of non-availability of both parents)
- Availability of affected relatives in population 2 (or validation of the indication in SPC in case of non-availability of the related person)
- Related:
- Major or minor patient
- Histological or cytological evidence of the diagnosis of malignant tumor if
- Patient affiliated to a social security scheme
- Signing informed consent EXTRICAN
Who cannot join
- Index and related case:
- Refusal of the patient participation
- Psychiatric illness and / or condition of the patient compromising the understanding of the information or the realization of the study
- Patient under guardianship, curatorship or safeguard of justice
- Pregnant woman
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Not yet recruiting
CHRU Jean Minjoz
Besançon
Marie-Agnès COLLONGE-RAME, 03 81 21 81 87, macollongerame@chu-besancon.fr
- Recruiting
Centre Georges-François Leclerc
Dijon, 21000
Sophie NAMBOT, Dr, 03 80 29 53 13, sophie.nambot@chu-dijon.fr
Emilie REDERSTORFF, PhD, 03 45 34 81 16, erederstorff@cgfl.fr
- Not yet recruiting
CHU de Dijon
Dijon
Sophie NAMBOT, Dr, 03 80 29 53 13, sophie.nambot@chu-dijon.fr
- Not yet recruiting
CHU de Reims
Reims
Anne DURLACH, Dr, 03 26 78 75 52, adurlach@chu-reims.fr
- Not yet recruiting
Polyclinique de Courlancy
Reims
Fanny BRAYOTEL, Dr, 03 26 77 22 89, Fbrayotel@groupe-courlancy.com
- Not yet recruiting
CH de Troyes
Troyes
Charlotte CAILLE BENIGNI, Dr, 03 25 49 49 14, charlotte.caille-benigni@hcs-sante.fr
About this study
5 to 10% of cancers are due to the presence of a constitutional genetic alteration. It can be inherited from parents (family form) or by accident, in the first moments of life after fertilization (sporadic form). In both cases, this genetic alteration is constitutional and transmissible to descendants. It is hereditary. When an hereditary early form is suspected, several well-known genes generally involved in genetic predispositions to cancer are found by a technique called " gene panel ". However, this analysis does not always identify the genetic predisposing factors for cancer. New techniques called "high-throughput exome sequencing (SHD-E)", allow more than the analysis of the the gene panel. These analysis allow to identify alterations in other genes that could contribute to the development of cancer. The objective of the Ex²trican study is to show, from patients with early cancer (sporadic or familial form), that this approach to exome sequencing can be effective to identify new genetic risk of cancer, when the first panel analysis of genes is negative.
Read the detailed description
The main objective of this study is to evaluate the interest of the SHD-E approaches after a negative result of the analysis called " gene panel " tested in routine in order to identify a genetic factor of predisposition to the cancer.
- Conditions
- Cancer, Genetic Predisposition
- Being tested
- blood sample
- Keywords
- genetic mutations, early sporadic or familial cancer, gene panel, exome analysis, high-throughput exome sequencing
- Medical subject headings
- Neoplasms, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleGenetic
blood test
| Study group | Role | What they receive |
|---|---|---|
| Patients with a a constitutional genetic alteration | Experimental | one genetic consultation and one blood test Receives: Genetic: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
genetic mutations
SHD-E analysis
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start7 Oct 2019
- Primary completion7 Apr 2028 (estimated)
- Study completion7 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- 613 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141462
- Sponsor's protocol ID
- EX²TRICAN
- Acronym
- EX²TRICAN
- Status last verified
- Apr 2026
- First submitted
- 23 Oct 2019
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXOME Analysis Position in the Strategy of Genetic Predisposition Factors Identification in Early-onset Cancer
- ClinicalTrials.gov ID
- NCT04141462
- Acronym / sponsor ID
- EX²TRICAN / EX²TRICAN
- Conditions
- Cancer, Genetic Predisposition
- Keywords
- genetic mutations, early sporadic or familial cancer, gene panel, exome analysis, high-throughput exome sequencing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 613 participants (estimated)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 7 Apr 2028 (estimated)
- Study completion
- 7 Apr 2028 (estimated)
- First posted
- 28 Oct 2019 (actual)
- 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.
5 to 10% of cancers are due to the presence of a constitutional genetic alteration. It can be inherited from parents (family form) or by accident, in the first moments of life after fertilization (sporadic form). In both cases, this genetic alteration is constitutional and transmissible to descendants. It is hereditary. When an hereditary early form is suspected, several well-known genes generally involved in genetic predispositions to cancer are found by a technique called " gene panel ". However, this analysis does not always identify the genetic predisposing factors for cancer. New techniques called "high-throughput exome sequencing (SHD-E)", allow more than the analysis of the the gene panel. These analysis allow to identify alterations in other genes that could contribute to the development of cancer. The objective of the Ex²trican study is to show, from patients with early cancer (sporadic or familial form), that this approach to exome sequencing can be effective to identify new genetic risk of cancer, when the first panel analysis of genes is negative.
Detailed description
The main objective of this study is to evaluate the interest of the SHD-E approaches after a negative result of the analysis called " gene panel " tested in routine in order to identify a genetic factor of predisposition to the cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a a constitutional genetic alteration | Experimental | Genetic: blood sampleone genetic consultation and one blood test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Major or minor patient
- Histological or cytological evidence of malignant tumor diagnosis
- Patient with cancer before age 40 (or before age 30 for breast cancer).
- Absence of anomaly found on the oncogenetic panel tested in the predisposition concerned
- Patient affiliated to a social security scheme
Key exclusion criteria (5 listed)
- Refusal of the patient participation
- Psychiatric illness and / or condition of the patient compromising the understanding of the information or the realization of the study
- Patient under guardianship, curatorship or safeguard of justice
- Pregnant woman
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 |
|---|---|---|
| blood sampleblood test | Genetic | Patients with a a constitutional genetic alteration |
Primary outcome
genetic mutations
Time frame: inclusion
SHD-E analysis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample in people with Cancer and Genetic Predisposition, run by Centre Georges Francois Leclerc at 6 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 15 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 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 6 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie NAMBOT, Dr (03 80 29 53 13, sophie.nambot@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
genetic mutations (time frame: inclusion). It is what the study was designed to measure, not a finding.
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 3 Apr 2026.