Clinical trial · Observational
Circulating Tumour DNA as a Marker of Residual Disease & Response to Adjuvant Chemotherapy in Stage I-IV Ovarian Cancer
Circulating Tumour DNA as a Marker of Residual Disease and Response to Adjuvant Chemotherapy in Stage I-IV Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer (EOC)
NCT03691012CI-TRIAL-00066256unknownClinicalTrials.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)
To demonstrate that detectable ctDNA in peripheral blood following debulking of the primary tumour or following completion of adjuvant treatment for is associated with subsequent disease recurrence in stage I-IV epithelial, fallopian tube and primary peritoneal cancer (Ovarian Cancer)
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 Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Circulating tumour DNA testing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Circulating DNA in the plasma of cancer patients has been shown to exhibit tumour-related alteration. These mutations in tumour cells,can be used as highly specific biomarkers of disease burden. Baseline.
- timeFrame
- After surgery (primary debulking group) or pre cycle 1 of therapy (neoadjuvant) confirmed with conventional radiological imaging and CA125 (cycles of chemotherapy are 21 days in length).
- description
- polymerase chain reaction (PCR) to quantify ctDNA
Secondary outcomes (5)
- measure
- Circulating DNA in the plasma of cancer patients has been shown to exhibit tumour-related alteration. These mutations in tumour cells can be used as highly specific biomarkers of disease burden. Change from baseline and previous result.
- timeFrame
- At the completion of pre cycle 3 of chemotherapy (primary debulking group) confirmed with Convential Radiological imaging and CA125. (each cycle 21 days in length)
- description
- polymerase chain reaction (PCR) to quantify ctDNA
- measure
- Circulating DNA in the plasma of cancer patients has been shown to exhibit tumour-related alteration. These mutations in tumour cells can be used as highly specific biomarkers of disease burden. Change from baseline and previous result.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients that have had primary debulking surgery for curatively resected stage I-IV high grade serous, endometrioid or clear cell carcinoma, or carcinosarcoma of the ovary, fallopian tube or primary peritoneum. Stage IV patients can only be included in the study if they have had a complete resection of all macroscopic disease with no residual disease. OR Patients commencing neoadjuvant chemotherapy for stage I- III high grade serous, endometrioid or clear cell carcinoma, or carcinosarcoma of the ovary, fallopian tube or primary peritoneum. Women must be planned to undergo interim debulking surgery. 2. A representative tumour sample can be made available for molecular testing after surgery or a core biopsy pre neoadjuvant chemotherapy if available. 3. Fit and planned for adjuvant chemotherapy Exclusion Criteria: 1. History of another primary cancer within the last 3 years 2. Patients with Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer (EOC) of mucinous subtype and sarcoma 3. Patients with Stage IV disease who have residual disease 4. Patients \<18 years
References
Publications (0)
Data not yet available
No reference posted for this study.