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Trial Title:
Detection of Homologous Recombination Pathway Gene Mutations in Circulating Tumour DNA From BRCA-mutated Ovarian Cancer Patients Receiving First-line PARP Inhibitor Maintenance Therapy
NCT ID:
NCT06588322
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Blood samples will be taken on several times (36 mL of blood taken at each time):
Description:
- Inclusion visit (T0): prior to initiation of Olaparib treatment
- Follow-up period (T1 to T8): every 3 months for a maximum of 24 months
- End of study (Tx): on definitive cessation of Olaparib treatment for any reason
(progression, toxicity or definitive cessation of treatment after 2 years).
Arm group label:
Patient with an epithelial ovarian cancer.
Summary:
This is an interventional (category 2), prospective, multicentric cohort study designed
to demonstrate that the search, based on Circulating tumour DNA analysis, for a BRCA1/2
reversion mutation leading to restoration of its protein function enables early
identification of disease progression in BRCA1/2 mutant patients treated as first-line
maintenance with a PARP inhibitor (Olaparib alone or in combination with bevacizumab) for
ovarian cancer.
For this study, a total of 9 blood samples will be taken from patients who will undergo a
full 24-month treatment regimen.
Apart from the study procedure (blood sampling), all examinations carried out in this
study, treatment with Olaparib (alone or combined with bevacizumab) and patient follow-up
procedures will be carried out as part of routine care in accordance with the standard
practices of each investigating site.
130 patients will take part in the study, and each patient will be followed for 24
months.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patient with an epithelial ovarian cancer.
2. Patient with a BRCA 1 or 2 somatic and/or constitutional mutation previously
confirmed and validated by an approved laboratory.
3. Patient due to start first-line maintenance treatment with Olaparib alone (PARP
inhibitor) or in combination with bevacizumab.
4. Age ≥ 18 years at the time of signing the consent.
5. WHO ≤ 1.
6. Patient affiliated to a Social Security scheme in France.
7. Patient having signed informed consent prior to inclusion in the study and prior to
any specific procedure for the study.
Exclusion Criteria:
1. Other cancer under treatment.
2. Olaparib treatment already initiated.
3. Indication for treatment with a PARP inhibitor other than Olaparib.
4. Any pathology contraindicating the sample collection procedures required by the
study.
5. Any psychological, family, geographical or sociological condition that makes it
impossible to comply with medical monitoring and/or the procedures laid down in the
study protocol.
6. Subjects deprived of their liberty or under legal protection.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Angers
Address:
City:
Angers
Country:
France
Status:
Recruiting
Contact:
Last name:
Jean-Sébastien FRENEL
Phone:
02 40 67 99 00
Email:
jean-sebastien.frenel@ico.unicancer.fr
Facility:
Name:
Institut Bergonie
Address:
City:
Bordeaux
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Coriolan LEBRETON
Phone:
05 56 33 32 79
Email:
c.lebreton@bordeaux.unicancer.fr
Facility:
Name:
Chu de Limoges
Address:
City:
Limoges
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Laurence VENAT
Phone:
05 55 05 63 96
Email:
laurence.venat@chu-limoges.fr
Facility:
Name:
Chu de Nimes
Address:
City:
Nimes
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Frédéric FITENI
Phone:
04 66 68 33 01
Email:
frederic.fiteni@chu-nimes.fr
Facility:
Name:
INSTITUT DE CANCEROLOGIE DE L'OUEST - Site Saint-Herblain
Address:
City:
Saint-Herblain
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Jean-Sébastien FRENEL
Phone:
02 40 67 99 00
Email:
jean-sebastien.frenel@ico.unicancer.fr
Facility:
Name:
IUCT-O
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Contact:
Last name:
Laurence GLADIEFF
Phone:
05 31 15 51 01
Email:
gladieff.laurence@iuct-oncopole.fr
Start date:
October 2024
Completion date:
October 2029
Lead sponsor:
Agency:
Institut Claudius Regaud
Agency class:
Other
Source:
Institut Claudius Regaud
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06588322
