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NCT04537702
Prospective Randomized Trial of Streamlined Genetic Education and Testing for Ovarian Cancer Patients
NA trial testing Streamlined Education in Ovarian Cancer, Epithelial in 64 participants. Completed in 31 July 2021.
31 July 2021
Quick facts
| Lead sponsor | Duke University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 64 |
| Start date | 8 August 2019 |
| Primary completion | 31 July 2021 |
| Estimated completion | 31 July 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Streamlined Education
- Traditional Education
Conditions studied
- Ovarian Cancer, Epithelial — all drugs for Ovarian Cancer, Epithelial →
- Peritoneal Cancer — all drugs for Peritoneal Cancer →
- Fallopian Tube Cancer — all drugs for Fallopian Tube Cancer →
Sponsor
Duke University
Who can join
18 and older, female only, with Ovarian Cancer, Epithelial or Peritoneal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Current guidelines recommend universal genetic testing for all patients with ovarian, fallopian and peritoneal cancer. The purpose of this trial is to investigate the non-inferiority of streamlined genetics education and testing for this patient population when compared to the traditional model of referral to genetic counseling. Patients will be randomized to either the streamlined or the traditional counseling arm. Those in the streamlined group will watch a brief educational video and have the option of immediate testing; The traditional counseling arm will instead be referred for a formal genetics consultation, after which they can choose to be tested. The primary outcome will be a patient reported outcome scale that assesses patient satisfaction with genetic counseling; patient anxiety and distress and cost effectiveness when using both strategies will also be evaluated. The study poses minimal risk to the patients that would not be encountered during standard of care genetic counseling.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04537702
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Ovarian Cancer, Epithelial
Currently open trials in the same condition.
- NCT06640348 — Ultrasensitive SERS Platform With Highly Efficient Enrichment of Analyte for Screening and Diagnosis of Epithelial Ovari · recruiting
- NCT05107674 — A Study of NX-1607 in Adults With Advanced Malignancies · Phase 1 · recruiting
Other Duke University trials
Trials by the same sponsor.
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- NCT07275359 — Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations · Phase 1 · not yet recruiting
- NCT07216963 — The Community Paramedic Response and Overdose Outreach With Supportive Medical-Legal Services Study · NA · not yet recruiting
- NCT07459218 — IDEAS for Hope to Reduce Suicide Risk and Improve HIV Care Engagement in Tanzania · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04537702 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Duke University
- Last refreshed: 26 August 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04537702.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing