Clinical trial NCT06242392: The Correlation Between HRD Detection and the Efficacy of PARP Inhibitors in Ovarian Cancer
Official title: The Correlation Between Homologous Recombination Deficiency Detection and the Efficacy of PARP Inhibitors in Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ovarian Neoplasms
Keywords: Ovarian Neoplasms
homologous recombination deficiency
prognosis
Cost-effectiveness analysis
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Fujian Provincial Hospital
First posted: 2024-02-05
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Ovarian Cancer who were treated from June 2020 to December 2026 and met the above inclusion and exclusion criteria

Brief summary: Clinicopathological data were collected from ovarian cancer patients treated with PARP inhibitors, with follow-up imaging conducted before and after treatment. The efficacy was evaluated according to RECIST criteria, comparing the correlation between different HRD statuses and the efficacy of PARP inhibitors in ovarian cancer.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with ovarian cancer (any histological type) and possessing complete pathological hematoxylin and eosin (HE) stained slides and paraffin-embedded tissue blocks.
* Patients must be 18 years of age or older.
* Patients should not have concurrent multiple primary cancers.
* Patients must undergo an MRI or CT scan prior to starting treatment.
* According to RECIST (Response Evaluation Criteria In Solid Tumors) criteria, patients must have at least one measurable lesion.
* Participants must provide informed consent, voluntarily cooperate with clinical follow-up, and sign an informed consent form.

Exclusion Criteria:

* Patients who do not have accessible tumor tissue required for Homologous Recombination Deficiency (HRD) testing.
* Patients whose clinical records are incomplete, making it impossible to effectively compare treatment efficacy.
* Patients who are lost to follow-up and for whom subsequent treatment outcomes cannot be tracked.

Primary outcomes:
measure: Efficacy of PARP inhibitors in the treatment of ovarian cancer
timeFrame: 2026-5-1
Secondary outcomes:
measure: cost-effectiveness analysis of using PARP inhibitors to treat cervical cancer
timeFrame: 2026-5-1
measure: PARP inhibitors in the treatment of ovarian cancer
timeFrame: 2026-5-1
Other outcomes:
Locations:
Study officials:
References:
citation: Miller RE, Leary A, Scott CL, Serra V, Lord CJ, Bowtell D, Chang DK, Garsed DW, Jonkers J, Ledermann JA, Nik-Zainal S, Ray-Coquard I, Shah SP, Matias-Guiu X, Swisher EM, Yates LR. ESMO recommendations on predictive biomarker testing for homologous recombination deficiency and PARP inhibitor benefit in ovarian cancer. Ann Oncol. 2020 Dec;31(12):1606-1622. doi: 10.1016/j.annonc.2020.08.2102. Epub 2020 Sep 28.
citation: Vergote I, Gonzalez-Martin A, Ray-Coquard I, Harter P, Colombo N, Pujol P, Lorusso D, Mirza MR, Brasiuniene B, Madry R, Brenton JD, Ausems MGEM, Buttner R, Lambrechts D; European experts' consensus group. European experts consensus: BRCA/homologous recombination deficiency testing in first-line ovarian cancer. Ann Oncol. 2022 Mar;33(3):276-287. doi: 10.1016/j.annonc.2021.11.013. Epub 2021 Dec 1.
citation: Lheureux S, Gourley C, Vergote I, Oza AM. Epithelial ovarian cancer. Lancet. 2019 Mar 23;393(10177):1240-1253. doi: 10.1016/S0140-6736(18)32552-2.
citation: Doig KD, Fellowes AP, Fox SB. Homologous Recombination Repair Deficiency: An Overview for Pathologists. Mod Pathol. 2023 Mar;36(3):100049. doi: 10.1016/j.modpat.2022.100049. Epub 2023 Jan 10.
citation: Ray-Coquard I, Pautier P, Pignata S, Perol D, Gonzalez-Martin A, Berger R, Fujiwara K, Vergote I, Colombo N, Maenpaa J, Selle F, Sehouli J, Lorusso D, Guerra Alia EM, Reinthaller A, Nagao S, Lefeuvre-Plesse C, Canzler U, Scambia G, Lortholary A, Marme F, Combe P, de Gregorio N, Rodrigues M, Buderath P, Dubot C, Burges A, You B, Pujade-Lauraine E, Harter P; PAOLA-1 Investigators. Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2416-2428. doi: 10.1056/NEJMoa1911361.
citation: Moore KN, du Bois A. Homologous recombination deficiency testing in first-line ovarian cancer. Ann Oncol. 2022 Mar;33(3):231-233. doi: 10.1016/j.annonc.2021.12.013. Epub 2022 Jan 8. No abstract available.