TumorsNCT05103969
Cohort of Tumors With POLE/D1 Mutation
An observational study of Tumors and POLE Exonuclease Domain Mutation, run by Federation Francophone de Cancerologie Digestive at 1 site in France.
Trial summary
Primary objective of this study is to identify and describe the clinico-biological and molecular characteristics of tumors with somatic POLE (Polymerase ɛ)/POLD1 mutation identified by molecular biology platforms for all stages and primary sites combined Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors, POLE Exonuclease Domain Mutation, POLD1 Gene Mutation
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 5 Oct 2021to 6 Oct 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: - Patient with a histologically proven tumor with a POLE or POLD1 mutation identified by molecular biology analysis, carried out within the framework of clinical practice in the platforms that have set up this research.
Who may be able to join
- Any tumor presenting a variant of the exonuclease domain of POLE (exons 9 to 14) classified as pathogenic by the project working group, including: the 4 hotspots of mutations described (codons 286 (P286R/H/L), 411 (V411L), 459 (S459F), 424 (L424/V/I), (2).
- Any tumor presenting a variant of the exonuclease domain of PolD1 (exons 8-12), classified as pathogenic by the project working group, including : C319Y(10).
- Diagnosis made from the date of launch of the cohort and in the previous year
- -Age ≥ 18 years
Who cannot join
- Tumor without POLE or POLD1 mutation
- Tumor with POLE mutation identified in research studies retrospective research
- Opposition of the patient to the registration of his data in the cohort
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU -hopital Rangeuil
Toulouse, 31059
Rosine GUIMBAUD, PhD MD, +33 (0)5 61 32 21 42, guimbaud.r@chu-toulouse.fr
About this study
Official title: Multicenter Prospective Cohort of Tumors With Pole/D1 Mutation
Primary objective of this study is to identify and describe the clinico-biological and molecular characteristics of tumors with somatic POLE (Polymerase ɛ)/POLD1 mutation identified by molecular biology platforms for all stages and primary sites combined
Read the detailed description
The identification of patients to be included will be done directly from the tumor genotyping platforms.
Indeed, they will be the direct source of the identification of all POLE (Polymerase ɛ) mutations.
The platforms will inform the project coordination unit of new cases of mutated cancers as well as the referent investigator, jointly they will be in charge of data entry.
The diagnostic and follow-up data of each patient will be collected prospectively.
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify and describe the clinico-biological and molecular characteristics of tumors with somatic POLE/POLD1 mutation identified by molecular biology platforms for all stages and primary sites
Collection and description of clinical and histo-pathological data of tumors with POLE/POLD1 mutation
Measured: October 2027
Molecular characterization of the identified POLE/POLD1 mutations
Molecular characterization of the identified POLE/POLD1 mutations and of the mutational profile associated with these mutations
Measured: October 2027
Overall survival and response to treatments
Analysis of overall survival and response to treatments (chemotherapies, immunotherapies...)
Measured: October 2027
Secondary outcomes (1)
database and block librabry
Establishment of a database of somatic POLE variants Establishment of a block library of POLE mutated tumors
Measured: October 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start5 Oct 2021
- Primary completion6 Oct 2025 (estimated)
- Study completion6 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federation Francophone de Cancerologie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosine GUIMBAUD, PhD.MD, Principal investigator, Fédération francophone de Cancérologie digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103969
- Sponsor's protocol ID
- POLE COHORT
- Status last verified
- Jul 2024
- First submitted
- 6 Oct 2021
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Cohort of Tumors With Pole/D1 Mutation
- ClinicalTrials.gov ID
- NCT05103969
- Acronym / sponsor ID
- POLE COHORT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Federation Francophone de Cancerologie DigestiveUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 6 Oct 2025 (estimated)
- Study completion
- 6 Oct 2025 (estimated)
- First posted
- 2 Nov 2021 (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.
Primary objective of this study is to identify and describe the clinico-biological and molecular characteristics of tumors with somatic POLE (Polymerase ɛ)/POLD1 mutation identified by molecular biology platforms for all stages and primary sites combined
Detailed description
The identification of patients to be included will be done directly from the tumor genotyping platforms.
Indeed, they will be the direct source of the identification of all POLE (Polymerase ɛ) mutations.
The platforms will inform the project coordination unit of new cases of mutated cancers as well as the referent investigator, jointly they will be in charge of data entry.
The diagnostic and follow-up data of each patient will be collected prospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - Patient with a histologically proven tumor with a POLE or POLD1 mutation identified by molecular biology analysis, carried out within the framework of clinical practice in the platforms that have set up this research.
Key inclusion criteria (4 listed)
- Any tumor presenting a variant of the exonuclease domain of POLE (exons 9 to 14) classified as pathogenic by the project working group, including: the 4 hotspots of mutations described (codons 286 (P286R/H/L), 411 (V411L), 459 (S459F), 424 (L424/V/I), (2).
- Any tumor presenting a variant of the exonuclease domain of PolD1 (exons 8-12), classified as pathogenic by the project working group, including : C319Y(10).
- Diagnosis made from the date of launch of the cohort and in the previous year
- -Age ≥ 18 years
Key exclusion criteria (3 listed)
- Tumor without POLE or POLD1 mutation
- Tumor with POLE mutation identified in research studies retrospective research
- Opposition of the patient to the registration of his data in the cohort
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To identify and describe the clinico-biological and molecular characteristics of tumors with somatic POLE/POLD1 mutation identified by molecular biology platforms for all stages and primary sites
Time frame: October 2027
Collection and description of clinical and histo-pathological data of tumors with POLE/POLD1 mutation
Molecular characterization of the identified POLE/POLD1 mutations
Time frame: October 2027
Molecular characterization of the identified POLE/POLD1 mutations and of the mutational profile associated with these mutations
Overall survival and response to treatments
Time frame: October 2027
Analysis of overall survival and response to treatments (chemotherapies, immunotherapies...)
1 secondary outcome
database and block librabry
Time frame: October 2027
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
Rosine GUIMBAUD, PhD.MD principal investigator
Fédération francophone de Cancérologie digestive
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 Tumors and POLE Exonuclease Domain Mutation, run by Federation Francophone de Cancerologie Digestive 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?
The sponsor lists 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ROSINE GUIMBAUD, PhD.MD (+33 (0)5 61 32 21 42, guimbaud.r@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify and describe the clinico-biological and molecular characteristics of tumors with somatic POLE/POLD1 mutation identified by molecular biology platforms for all stages and primary sites (time frame: October 2027). The study lists 3 primary outcomes in all. 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 8 Jul 2024.