NCT03159572

Brief Summary

To investigate the frequency and clinical significance of Homologous Recombination Deficiency (HRD) in Japanese patients with ovarian cancer (including Fallopian tube cancer and primary peritoneal cancer).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
996

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2022

Completed
Last Updated

November 21, 2024

Status Verified

January 1, 2023

Enrollment Period

4.9 years

First QC Date

May 17, 2017

Last Update Submit

November 18, 2024

Conditions

Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cancer

Keywords

Ovarian cancerFallopian tube cancerPrimary peritoneal cancerGermline Breast Cancer Susceptibility Gene (BRCA1/2 gene)Homologous Recombination Deficiency (HRD)

Outcome Measures

Primary Outcomes (1)

  • Frequency of HRD in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)

    When all tumor samples are stored at ToMMo after the term of registration, DNA are extracted from frozen tumor tissue. These extracted tumor DNA, after confirmed at inspection body that it has constant qualities, are examined for HRD by DNA target sequencing.

    17 months

Secondary Outcomes (2)

  • Association between Progression Free Survival (PFS) / Response Rate and HRD in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)

    48 months

  • Association between Progression Free Survival (PFS) / Response Rate and germline mutation in BRCA1/2 gene in patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer)

    48 months

Study Arms (1)

Ovarian cancer group

Patients who are diagnosed with ovarian cancer and have a plan of surgery.

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult ovarian cancer patients who provided written informed consent including providing tumor tissue specimens before surgery.

You may qualify if:

  • Patients who can approve informed consent and sign it. Patients who show their will to participate in this study and can sign the informed consent forms by themselves.
  • Patients who are clinically diagnosed as having ovarian cancer and can provide written informed consent before the surgery.
  • Patients who can provide tumor tissue specimens. (except ascites cytology and cell block specimens)
  • Patients who are 20 years old and over at the enrollment.
  • Patients with ECOG Performance status (PS): 0-2.

You may not qualify if:

  • Patients with active concomitant malignancy\* except breast cancer.
  • \*Includes synchronous multiple cancer and metachronous multiple cancer with less than 5 years of disease free survival. However, excludes skin basal cell carcinoma, skin squamous cell carcinoma, and any other curable lesions with local therapy such as carcinoma in situ or intramucosal carcinoma.
  • Patients who are diagnosed as any other acute/chronic, physically/mentally severe diseases and judged by the primary physician as inappropriate to enroll this study because of safety reasons or any influence to study outcomes.
  • Any other cases that are inappropriate to enroll this study, judged by study principal investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niigata University Graduate School of Medical and Dental Sciences

Niigata, Niigata, 951-8510, Japan

Location

Biospecimen

Retention: SAMPLES WITH DNA

tumor tissue

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Study Officials

  • Takayuki Enomoto, MD, Ph.D

    Department of Obstetrics and Gynecology, Niigata University Graduate School of Medical and Dental Sciences

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 18, 2017

Study Start

March 28, 2017

Primary Completion

February 16, 2022

Study Completion

February 16, 2022

Last Updated

November 21, 2024

Record last verified: 2023-01

Locations

JP(1)