NCT04190667

Brief Summary

The homologous recombination deficiency (HRD) status in Chinese population with epithelial ovarian cancer (EOC) is little known. This study would recruit 1300 Chinese EOC patients. A multi-panel testing of 36 genes would be given for these patients in their peripheral blood and tumor tissues. These 36 genes include: BRCA1, BRCA2, ABRAXAS1(FAM175A）, ATM, ATR, BAP1, BARD1, BRIP1, C11ORF30（EMSY）, CDK12, CHEK1, CHEK2, FANCA, FANCC, FANCD2, FANCI, FANCL, MRE11A, NBN, PALB2, PPP2R2A, PTEN, RAD50, RAD51B, RAD51C, RAD51D, RAD54B, RAD54, MLH1, MSH2, MSH6, PMS2, EPCAM, STK11, TP53, CDH1. The study would select 150 patients with pathogenic or likely pathogenic mutations in BRCA1/2 and 150 patients without these mutations to further explore the HRD status. The HRD model is based on the loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST). The mutated genes, HRD score model and their relationship with the prognosis, would provide a full description of for the Chinese EOC patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 4, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

December 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2022

Completed
Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

2 years

First QC Date

December 4, 2019

Last Update Submit

December 6, 2019

Conditions

Epithelial Ovarian CancerChineseHomologous Recombination DeficiencyBRCA1 MutationBRCA2 MutationPrognosis

Outcome Measures

Primary Outcomes (2)

  • Frequency of targeted genetic mutations

    Frequency of pathogenic or likely pathogenic mutations in a multi-panel genes

    Two years

  • Homologous recombination deficiency (HRD) score

    The HRD score for individual patient is a scale describing her HRD status. The score model is calculated by the analysis for three types of important molecular mechanism: loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST)

    Two years

Secondary Outcomes (4)

  • Progression-free survival

    Two years

  • Overall survival

    Two years

  • Rate of sensitivity to platinum-based chemotherapy

    Two years

  • Rate of sensitivity to poly-(ADP-ribose) polymerase inhibitors

    Two years

Interventions

Genomic testingDIAGNOSTIC_TEST

A multi-panel testing of 36 genes would be given for these patients in their peripheral blood and tumor tissues. These 36 genes include: BRCA1, BRCA2, ABRAXAS1(FAM175A）, ATM, ATR, BAP1, BARD1, BRIP1, C11ORF30（EMSY）, CDK12, CHEK1, CHEK2, FANCA, FANCC, FANCD2, FANCI, FANCL, MRE11A, NBN, PALB2, PPP2R2A, PTEN, RAD50, RAD51B, RAD51C, RAD51D, RAD54B, RAD54, MLH1, MSH2, MSH6, PMS2, EPCAM, STK11, TP53, CDH1. The study would select 150 patients with pathogenic or likely pathogenic mutations in BRCA1/2 and 150 patients without these mutations to further explore the HRD status.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chinese population with confirmed diagnosis of epithelial ovarian cancer

You may qualify if:

  • Aged 18 years or older
  • Pathological confirmation of epithelial ovarian cancer
  • With available tumor tissues
  • Given consents to participate the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples from the patients' peripheral blood and tumor tissues.

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

Genetic Profile

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Genetic BackgroundGenetic Phenomena

Study Officials

  • Lei Li

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li

CONTACT

+8613911988831lileigh@163.com

Ming Wu

CONTACT

+8613810224549wuming@pumch.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 4, 2019

First Posted

December 9, 2019

Study Start

December 7, 2019

Primary Completion

December 7, 2021

Study Completion

December 7, 2022

Last Updated

December 10, 2019

Record last verified: 2019-12

Locations

CN(1)