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NCT Number: NCT03159572

Homologous Recombination Inquiry Through Ovarian Malignancy Investigations

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).

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Primary Peritoneal Cancer Urogenital Diseases Urogenital Neoplasms

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Niigata University Graduate School of Medical and Dental Sciences

Niigata, 951-8510, Japan

About this study

In this study, investigators plan to clarify the frequency of Homologous Recombination Deficiency (HRD) in Japanese patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer).

And investigators will also investigate whether HRD-positive ovarian cancer patients show the clinical characteristics of highly platinum-sensitivity and good prognosis, comparing to HRD-negative ovarian cancer patients.

In addition, it is planned to investigate any association between Progression Free Survival (PFS) / Platinum-Sensitivity and germline mutation in Breast Cancer Susceptibility Gene (BRCA1/2 gene) in ovarian cancer patients who can provide the patients' gBRCA1/2 gene information for this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

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

    Time frame: 17 months

    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.

Secondary outcomes

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

    Time frame: 48 months

    PFS is calculated from registration date to the date diagnosed as progression or the date of death from any cause, whichever comes earlier. Response rate(RR) is determined the rate of patients who are evaluated of best overall response as CR(complete response) or PR(partial response) from those with measurable disease (based on Guidelines to Evaluate the Response to Treatment in Solid Tumors, RESIST).

    Association between PFS/RR and HRD which is clarified as primary outcome is assessed.

  2. 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)

    Time frame: 48 months

    PFS is calculated from registration date diagnosed as having progression or the date of death from any cause, whichever comes earlier. Response rate(RR) is determined the rate of patients who are evaluated of best overall response as CR(complete response) or PR(partial response) from those with measurable disease (based on Guidelines to Evaluate the Response to Treatment in Solid Tumors, RESIST).

    Association between PFS/RR and gBRCA1/2 gene information from patients who can provide their gBCRA1/2 gene information with their informed consent, is evaluated.

Sponsors and collaborators

Lead sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Other

Collaborators

  • Department of Obstetrics and Gynecology, School of Medicine, Niigata University
  • Japanese Gynecologic Oncology Group
  • Tohoku Medical Megabank Organization(ToMMo)

Registry information

Acronym: HITOMI

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
May 18, 2017
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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