Clinical trial · Interventional
Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma
NCT03302884CI-TRIAL-00040859CIDOCunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective multicentre assay to assess ctDNA value for ovarian cancer monitoring and disease recurrence after front-line treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biological sampling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Biological sampling in ovarian carcinoma
- description
- Blood and tumor samples
- interventionNames
- Other: biological sampling
Primary outcomes (1)
- measure
- Prognostic value of ctDNA increase for predicting a subsequent clinical, radiological (RECIST v1.1) or biological (CA-125 according to GCIG criteria) diagnosis of disease relapse.
- timeFrame
- at diagnosis, after each cycle of eventual neo-adjuvant chemotherapy, before surgery, then every six months during the next two years, and every year in the following three years
- description
- Re-appearance of mutations non detectable after treatment or increase of ctDNA comparing to the nadir
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient with suspicion of ovarian or tubar epithelial cancer, or peritoneal primitive carcino-ma, without previous treatment for ovarian malignancy. 2. Indication of preoperative and/or adjuvant chemotherapy. 3. Age ≥ 18 years old. 4. Patient affiliated to the ''National security'' regimen or beneficiary of this regimen 5. Signed written informed consent prior to any screening procedures being performed Non inclusion Criteria: 1. Contraindication to surgical assessment. 2. Pathological diagnosis of mucinous carcinoma. 3. History of concurrent malignancy or malignancy within 5 years before study enrollment, (with the exceptions of adequately treated non melanomatous skin cancer or curatively re-sected noninvasive cervical cancer). 4. Assessment by the investigator as being unable or unwilling to comply with the require-ments of the protocol. 5. Patient in urgency situation, adult under legal protection, or unable to give his consent. Exclusion Criteria after histological exam: Any diagnostic that is not ovarian or tubar epithelial cancer, or peritoneal primitive carcinoma.
References
Publications (0)
Data not yet available
No reference posted for this study.