The Correlation Between HRD Detection and the Efficacy of PARP Inhibitors in Ovarian Cancer

NCT06242392 | Not Yet Recruiting

• 1 other identifier: ChenJian2
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ovarian Neoplasms

Keywords

Ovarian Neoplasms; homologous recombination deficiency; prognosis; Cost-effectiveness analysis

Outcome Measures

Primary Outcomes (1)

• Efficacy of PARP inhibitors in the treatment of ovarian cancer

  Progression-Free Survival (PFS) is used to evaluate the efficacy of PARP inhibitor treatment in ovarian cancer with different HRD (Homologous Recombination Deficiency) statuses.

  2026-5-1

Secondary Outcomes (2)

• cost-effectiveness analysis of using PARP inhibitors to treat cervical cancer

  2026-5-1

• PARP inhibitors in the treatment of ovarian cancer

  2026-5-1

Study Arms (2)

effective group

The tumor size of each diameter of the tumor before and after treatment was measured on magnetic resonance imaging or CT. According to Recist 1.1 criteria, patients who were evaluated as complete remission, partial remission and stable disease were included in the effective group. Patients assessed as having progressive disease were included in the treatment-refractory group.

Genetic: homologous recombination deficiency

ineffective group

The tumor size of each diameter of the tumor before and after treatment was measured on magnetic resonance imaging or CT. According to Recist 1.1 criteria. Patients assessed as having progressive disease were included in the ineffective group.

Genetic: homologous recombination deficiency

Interventions

homologous recombination deficiency GENETIC

Homologous Recombination Deficiency (HRD) refers to a disruption or deficiency in the homologous recombination repair (HRR) pathway, which is a crucial mechanism in cells for repairing DNA double-strand breaks (DSBs). This pathway is particularly important for maintaining genomic stability.

effective group; ineffective group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead
• Fujian Provincial Hospital: collaborator

Related Publications (6)

• 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.

  PMID: 33004253 BACKGROUND

• 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.

  PMID: 34861371 BACKGROUND

• 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.

  PMID: 30910306 BACKGROUND

• 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.

  PMID: 36788098 BACKGROUND

• 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.

  PMID: 31851799 BACKGROUND

• 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.

  PMID: 35017033 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Jian FC Chen

CONTACT

+8615806030009; marsz3@126.com

Yang Sun

CONTACT

15959028989; doctorsunyang@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 5, 2024
• Study Start: January 31, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share