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Hysterectomy and OPPortunistic SAlpingectomy

NCT03045965Active, Not RecruitingNAINTERVENTIONAL

Summary

HOPPSA is a register based randomized controlled trial (R-RCT), with the objective to examine if opportunistic salpingectomy compared with no salpingectomy, at the time of hysterectomy for a benign reason * has no increased risk of complications * has no negative side effects on ovarian function and subsequent cardiovascular disease or incidence of fractures * implies reduced risk of subsequent ovarian cancer Randomization and follow-up will be conducted within national registers.

Key Facts

Lead Sponsor

Göteborg University

Enrollment

4400

Start Date

2017-06-01

Completion Date

2026-06-01

Study Type

INTERVENTIONAL

Official Title

Hysterectomy and Opportunistic Salpingectomy

Interventions

Salpingectomy

Conditions

Ovarian CancerComplication

Eligibility

Age Range

20 Years – 54 Years

Sex

FEMALE

Inclusion Criteria:

* Planned hysterectomy for a benign reason
* Age \< 55 years at randomization
* Willing to be randomized
* Vaginal route may be included if the surgeon is confident with performing vaginal salpingectomy.

Exclusion Criteria:

* Previous bilateral oophorectomy and/or salpingectomy
* Planned oophorectomy and/or salpingectomy (for reasons such as already diagnosed adnexal tumor, known carrier of the breast cancer susceptibility gene (BRCA) 1/2 mutation or Lynch syndrome (hereditary nonpolyposis colorectal cancer))
* Non-understanding of the oral or written study information

Outcome Measures

Primary Outcomes

Surgical complication - short term primary outcome

Dichotomous outcome, retrieved from any of two sources in the GynOp register: specified question on complications and the Clavien-Dindo classification

Time frame: Eight weeks post-operative

Change in menopausal symptom score - intermediate term primary outcome

Measured from baseline to one year follow-up, assessed with Menopause Rating Scale (MRS)

Time frame: One year after surgery

Epithelial ovarian cancer - long term primary outcome

The outcome is dichotomous, the diagnosis is classified according to ICD10. Each case with a positive outcome is further described with histopathological types and grade, as well as clinical stage according to International Federation of Gynecology and Obstetrics (FIGO). Assessed through national registers stage according to International Federation of Gynecology and Obstetrics (FIGO). Assessed through national registers

Time frame: 10-30 years after surgery

Secondary Outcomes

Operative time

Continous outcome, registered in minutes

Time frame: At day of surgery

Length of hospital stay

Continous outcome, registered in days

Time frame: Assessment will be done at discharge from hospital after surgery, including a period up to 8 weeks. a

Perioperative blood loss

Continous outcome, registered in ml

Time frame: At day of surgery

Conversion to other surgical route

Dichotomous outcome

Time frame: At day of surgery

Failure rate of salpingectomy at planned vaginal hysterectomy

Dichotomous outcome

Time frame: At day of surgery

Prevalence of menopausal symptoms of at least moderate level according to Menopause Rating Scale (MRS)

Dichotomous outcome based on MRS

Time frame: One and five years after surgery

Ovarian function, measured as change in anti-Müllerian hormone (AMH) serum level, from baseline

Continous outcome, measured in mg/L

Time frame: One year after surgery

Subsequent adnexal surgery, including all surgery engaging salpinges and/or ovaries

Dichotomous outcome, accompanied by a description of number and types of surgery performed

Time frame: At one and up to ten years after surgery

Use of Hormone Replacement Therapy (HRT)

Dichotomous outcome

Time frame: At one and up to ten years after surgery

Cardiovascular disease

Dichotomous outcome, accompanied by the specific ICD diagnoses

Time frame: 10-30 years after surgery

Fractures (primarily radial, vertebral and hip fractures)

Dichotomous outcome, accompanied by the specific ICD diagnoses

Time frame: 10-30 years after surgery

Locations

Sahlgrenska University Hospital, Gothenburg, Sweden

Linked Papers

2023-03-24

HOPPSA update: changes in the study protocol of Hysterectomy and OPPortunistic SAlpingectomy, a registry-based randomized controlled trial

Abstract Background The HOPPSA trial is a multi-center national registry-based randomized controlled trial to test the safety and effectiveness of performing opportunistic salpingectomy at hysterectomy to reduce the risk of epithelial ovarian cancer (EOC). The study protocol was first published in January 2019 and is available at https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-3083-8. Here, we report amendments made to the study protocol since commencement of the trial. Changes in methods and analysis The primary outcomes analyses have been changed. (1) Complications will be analyzed using binomial generalized estimating equation (GEE) with log link function, while the unadjusted analyses according to Miettinen and Nurminen will be performed as a sensitivity analysis. (2) Absolute change in Menopause Rating Scale (MRS) will primarily be analyzed using a mixed effects model, adjusted for baseline MRS and center as a random effect. (3) Time to EOC will be analyzed using the mixed effects Cox regression model with center as random effect, while the unadjusted log-rank test will be performed as a sensitivity analysis. The primary outcome Complications will be based solely on the specific assessment in the GynOp quality registry. The Clavien-Dindo classification will be evaluated as a secondary outcome. Furthermore, MRS is also measured three years postoperatively to better pinpoint the onset of menopausal symptoms. Discussion The changes to the protocol mainly concern the analyses of data. No changes to recruitment, randomization, intervention, or follow-up of primary outcomes have been made. An interim analysis during 2021 concluded that the study should continue until the target sample size is reached. Trial registration ClinicalTrials.gov, NCT03045965. Registered 8 February 2017.

Linked Investigators

Annika Idahl