NCT03159572|CompletedDMC
Homologous Recombination Inquiry Through Ovarian Malignancy Investigations
HITOMI
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HITOMI
Sponsor study identifier
Secondary identifiers
OTHER · UMIN-CTR
observational
996
1 country
1
Study Start
March 28, 2017
Actual (reported)Primary Completion
February 16, 2022
Actual (reported)Study Completion
February 16, 2022
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 16, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 28, 2017
Actual (reported)May 17, 2017
Actual (reported)May 18, 2017
Actual (reported)February 16, 2022
Actual (reported)February 16, 2022
Actual (reported)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
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)
Patients who are diagnosed with ovarian cancer and have a plan of surgery.
Adult ovarian cancer patients who provided written informed consent including providing tumor tissue specimens before surgery.
Niigata University Graduate School of Medical and Dental Sciences
Niigata, Niigata, 951-8510, Japan
tumor tissue
Takayuki Enomoto, MD, Ph.D
Department of Obstetrics and Gynecology, Niigata University Graduate School of Medical and Dental Sciences
996 participants (actual enrollment reported by the registry).
First Submitted
May 17, 2017
First Posted
May 18, 2017
Study Start
March 28, 2017
Actual (reported)48 months
Contact the study team to confirm eligibility.
Primary Completion
February 16, 2022
Actual (reported)Study Completion
February 16, 2022
Actual (reported)Last Updated
November 21, 2024
Record last verified: 2023-01
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Source: ClinicalTrials.gov.
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