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NCT02595281: PRONOV4IR
HE4 as a Relapse Biomarker in Ovarian Cancers
NA trial testing Experimental arm in Ovarian Carcinoma in 90 participants. Completed in 18 July 2022.
18 July 2022
Quick facts
| Lead sponsor | Institut de Cancérologie de Lorraine |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 90 |
| Start date | 1 April 2016 |
| Primary completion | 18 July 2022 |
| Estimated completion | 18 July 2022 |
| Sites | 7 locations across France |
Drugs / interventions tested
- Experimental arm
Conditions studied
- Ovarian Carcinoma — all drugs for Ovarian Carcinoma →
Sponsor
Institut de Cancérologie de Lorraine — full company profile →
Who can join
18 and older, female only, with Ovarian Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
HE4 is a more sensitive marker than CA-125 in patients with ovarian cancers. The interest of serum HE4 before surgery has been demonstrated to predict overall survival and its interest has also been shown in combination with CA-125 (ROMA algorithm) to identify high risk patients. To date, no study shows clearly the predictive potential of serum HE4 as an early relapse biomarker in ovarian cancers.
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 NCT02595281
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT02595281 (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 Institut de Cancérologie de Lorraine
- Last refreshed: 19 December 2022
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/NCT02595281.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing