NCT06490380Completed
HRD Status Reference Standard Based on WGS
A Collaborative Project Aimed to Establish a WGS-based Reference Standard for Evaluating the Analytical Performance of HRD Status Testing
Source: ClinicalTrials.gov · Last updated 8 Jul 2024
Brief summary (registry, in English)
When evaluating the analytical performance of homologous recombination deficiency (HRD) status testing, there is currently no widely accepted reference standard. Therefore, a collaborative project was initiated to establish a HRD status reference standard for the industry. Although there is no genotyping strategy that is universally recognized as the most accurate for evaluating HRD status, whole-genome sequencing (WGS) is one of the best candidates.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 100 (actual)
- First submitted
- 30 Jun 2024
- Start date
- 30 Dec 2022
- Primary completion date
- 13 Dec 2023
- Lead sponsor
- Lei Li
- Diseases
- Ovarian cancer
- NCT number
- NCT06490380
What you commit to
- Study type: Observational
- Participants enrolled: 100
- From 30 Dec 2022 to the primary completion date, 13 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- First-line surgery not conducted
- Total round of first-line chemotherapy (neoadjuvant and adjuvant) less than 5
- First-line PARPi maintenance therapy initiated beyond 12 weeks after last dose of chemotherapy
Other
- Genotyping quality-control failed
Who the study is looking for
- At least 18 years of age at diagnosis
- Ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
- High-grade serous or high-grade endometroid histological type
- FIGO stage II, III, or IV
- Complete response or partial response following completion of first-line adjuvant chemotherapy
- PARPi administered as first-line maintenance therapy
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lei Li Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.