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Clinical Trials/KCT0007701
KCT0007701
Not yet recruiting
未知

A NON-RANDOMIZED PROSPECTIVE CLINICAL TRIAL COMPARING THE NON-INFERIORITY OF SALPINGECTOM TO SALPINGO-OOPHOPECTOMY TO REDUCE THE RISK OF OVARIAN CANCER AMONG BRCA1 CARRIERS [SOROCk]

Chung-Ang Univerisity Hospital0 sites2,262 target enrollmentTBD
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Chung-Ang Univerisity Hospital
Enrollment
2262
Status
Not yet recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional Study
Sex
Female

Investigators

Sponsor
Chung-Ang Univerisity Hospital

Eligibility Criteria

Inclusion Criteria

  • •1\. Women 35\-50 years of age, inclusive
  • •2\. Patients who have declined or elected to defer risk\-reducing salpingo\-oophorectomy (RRSO) after proper
  • •counselling to clearly explain the standard of care for BRCA1 mutation carriers (for the BLS with delayed
  • •oophorectomy arms) or patients who are undergoing RRSO (for the RRSO arm)
  • •3\. At least one intact ovary and fallopian tube is in situ at the time of counseling and consent. Prior
  • •hysterectomy is allowed provided it did not include bilateral salpingectomy. Prior tubal ligation is allowed if
  • •one intact ovary and tube are present
  • •4\. Positive Clinical Laboratory Improvement Act (CLIA)\-approved test results for pathogenic or likely
  • •pathogenic germline BRCA1 mutation in the patient herself. Documentation of the result is required
  • •6\. Premenopausal; defined as \< 12 months of amenorrhea. However, for those patients with \>\= 12 months of

Exclusion Criteria

  • •1\. Women with a history of any prior cancer who have received chemotherapy within the past 12 months,
  • •hormonal therapy in the past 90 days, or radiotherapy to abdomen or pelvis at any prior time
  • •2\. Prior history of ovarian cancer, including low malignant potential neoplasms (LMP), primary peritoneal
  • •carcinoma, or fallopian tube carcinoma
  • •3\. Patients medically unfit for the planned surgical procedure
  • •4\. Patients with abnormal screening tests (TVUS, CA\-125\) suspicious for occult or gross pelvic malignancy or
  • •neoplasm within the past 180 days
  • •\- An abnormal TVUS is defined as morphologic or structural variations suspicious for ovarian malignancy or
  • •complex cystic lesions (simple cysts \< 5 cm in maximal diameter are not exclusionary)
  • •\- An abnormal CA\-125 is defined as a level \> 50 U/ml in this study population of premenopausal women if

Outcomes

Primary Outcomes

Not specified

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