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Not yet recruitingNCT06242392Updated Feb 5, 2024

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

An observational study in Ovarian Neoplasms, sponsored by Fujian Cancer Hospital. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-05.

Sponsored by Fujian Cancer Hospital · Observational

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
250
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Ovarian Neoplasms

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Keywords

  • Ovarian Neoplasms
  • homologous recombination deficiency
  • prognosis
  • Cost-effectiveness analysis
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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 250 is above the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Fujian Cancer Hospital is the lead sponsor of 155 studies on the registry; 90 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
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

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

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.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
250 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Genetichomologous recombination deficiency

    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.

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What researchers measure

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.

    Time frame: 2026-5-1

Secondary outcomes

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

    The main economic outcome is the ICER.Health benefits were expressed as life years (LYs), and quality-adjusted life-years (QALYs) gained. The ICER was calculated by dividing the incremental cost difference between the two strategies, by the incremental difference in health outcomes (LYs and QALYs). Probabilistic Sensitivity Analysis (PSA) was performed to assess the impact of uncertainty around the key parameters of the model on the ICER. A second-order Monte Carlo simulation with 1000 iterations was used to run replicated outcomes. The normal distributions used for costs, utility and reimbursement ratio were carried to the specific limits.

    Time frame: 2026-5-1

  2. PARP inhibitors in the treatment of ovarian cancer

    Overall survival (OS) was used toevaluate the efficacy of PARP inhibitor treatment in ovarian cancer with different HRD (Homologous Recombination Deficiency) statuses.

    Time frame: 2026-5-1

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 33004253 ↗
  • 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. PubMed 34861371 ↗
  • 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. PubMed 30910306 ↗
  • 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. PubMed 36788098 ↗
  • 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. PubMed 31851799 ↗
  • 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. PubMed 35017033 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06242392
Lead sponsor
Fujian Cancer Hospital
Collaborators
Fujian Provincial Hospital
Responsible party
Sponsor
First posted
Feb 5, 2024
Start date
Jan 31, 2024 (estimated)
Primary completion
May 1, 2026 (estimated)
Completion
Jul 1, 2026 (estimated)
Last update
Feb 5, 2024

Study contacts

Jian FC Chen
Contact
marsz3@126.com
+8615806030009
Yang Sun
Contact
doctorsunyang@sina.com
15959028989

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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