NCT06622798

Brief Summary

This study plans to retrospectively include 470 initial surgical specimens from 470 patients with epithelial ovarian, fallopian tube or primary peritoneal cancers who were treated with PARPi maintenance therapy in the hospital from 2018.01 to 2024.01. All patients included would be scored by the proprietary HRD ADx-GSS® algorithm with the detecting results of the three genomic statuses including heterozygous omission (LOH), telomere allelic imbalance (TAI), and large-segment translocation (LST). Finally, the correlation between the HRD scores and the prognosis of Chinese ovarian cancer patients and the efficacy of using PARPi as maintenance treatment would be explored.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
470

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Aug 2024Jul 2026

Study Start

First participant enrolled

August 20, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 29, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 2, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2026

Expected
Last Updated

October 2, 2024

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

September 29, 2024

Last Update Submit

September 29, 2024

Conditions

Exploring the Correlation of HRD Score Pairs with the Prognosis of Chinese Ovarian Cancer Patients and the Outcome of Maintenance Therapy with PARPi

Keywords

HRDPARPi

Outcome Measures

Primary Outcomes (1)

  • HRD score

    Homologous recombination deficiency score

    2 years

Interventions

Non-interventionalOTHER

Non-interventional

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study was conducted in female patients with advanced epithelial ovarian, fallopian tube, and primary peritoneal cancers
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer

You may qualify if:

  • Patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer initially diagnosed after January 2015 or platinum-sensitive recurrent patients diagnosed with advanced epithelial ovarian, fallopian tube, and primary peritoneal cancers, and are treated with PARPi maintenance therapy by January 2024 after chemotherapy or Platinum-sensitive recurrent patients diagnosed with advanced epithelial ovarian, fallopian tube, and primary peritoneal cancers, and are treated with PARPi maintenance therapy by January 2024 after chemotherapy;
  • Age ≥ 18 years, female;
  • Stable CA125 level, ECOG: 0-2 points, and appropriate cardiac, liver and renal function before using PARPi.

You may not qualify if:

  • other malignancies combined within 5 years;
  • poor underlying condition, one of the following: ECOG PS score \>2, KPS score \<60, cardiac insufficiency (Class III-IV), hepatic insufficiency (Child-Pugh Class C), renal insufficiency (Stage 4-5);
  • patients whose sample residuals and quality do not support the need for testing;
  • conditions that, in the judgement of the investigator, may affect the conduct of the clinical study and the determination of the study results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen memorial hospital

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (6)

  • da Cunha Colombo Bonadio RR, Fogace RN, Miranda VC, Diz MDPE. Homologous recombination deficiency in ovarian cancer: a review of its epidemiology and management. Clinics (Sao Paulo). 2018 Aug 20;73(suppl 1):e450s. doi: 10.6061/clinics/2018/e450s.

    PMID: 30133561BACKGROUND

  • Bryant HE, Schultz N, Thomas HD, Parker KM, Flower D, Lopez E, Kyle S, Meuth M, Curtin NJ, Helleday T. Specific killing of BRCA2-deficient tumours with inhibitors of poly(ADP-ribose) polymerase. Nature. 2005 Apr 14;434(7035):913-7. doi: 10.1038/nature03443.

    PMID: 15829966BACKGROUND

  • Oldenburg J, Aparicio J, Beyer J, Cohn-Cedermark G, Cullen M, Gilligan T, De Giorgi U, De Santis M, de Wit R, Fossa SD, Germa-Lluch JR, Gillessen S, Haugnes HS, Honecker F, Horwich A, Lorch A, Ondrus D, Rosti G, Stephenson AJ, Tandstad T. Personalizing, not patronizing: the case for patient autonomy by unbiased presentation of management options in stage I testicular cancer. Ann Oncol. 2015 May;26(5):833-838. doi: 10.1093/annonc/mdu514. Epub 2014 Nov 6.

    PMID: 25378299BACKGROUND

  • Moore K, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Banerjee S, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley W, Mathews C, Liu J, Lowe ES, Bloomfield R, DiSilvestro P. Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2018 Dec 27;379(26):2495-2505. doi: 10.1056/NEJMoa1810858. Epub 2018 Oct 21.

    PMID: 30345884BACKGROUND

  • Lorusso D, Mouret-Reynier MA, Harter P, Cropet C, Caballero C, Wolfrum-Ristau P, Satoh T, Vergote I, Parma G, Nottrup TJ, Lebreton C, Fasching PA, Pisano C, Manso L, Bourgeois H, Runnebaum I, Zamagni C, Hardy-Bessard AC, Schnelzer A, Fabbro M, Schmalfeldt B, Berton D, Belau A, Lotz JP, Gropp-Meier M, Gladieff L, Luck HJ, Abadie-Lacourtoisie S, Pujade-Lauraine E, Ray-Coquard I. Updated progression-free survival and final overall survival with maintenance olaparib plus bevacizumab according to clinical risk in patients with newly diagnosed advanced ovarian cancer in the phase III PAOLA-1/ENGOT-ov25 trial. Int J Gynecol Cancer. 2024 Apr 1;34(4):550-558. doi: 10.1136/ijgc-2023-004995.

    PMID: 38129136BACKGROUND

  • 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: 31851799BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

surgical tumor tissue

Study Officials

  • Jing Li, M.D. Ph.D

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Li, M.D. Ph.D

CONTACT

15915893493lijing228@mail.sysu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate chief physician

Study Record Dates

First Submitted

September 29, 2024

First Posted

October 2, 2024

Study Start

August 20, 2024

Primary Completion

January 1, 2025

Study Completion (Estimated)

July 7, 2026

Last Updated

October 2, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)