Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma
CIDOC
1 other identifier
interventional
150
1 country
3
Brief Summary
Prospective multicentre assay to assess ctDNA value for ovarian cancer monitoring and disease recurrence after front-line treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2018
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2017
CompletedFirst Posted
Study publicly available on registry
October 5, 2017
CompletedStudy Start
First participant enrolled
October 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2023
CompletedSeptember 26, 2019
September 1, 2019
5.1 years
October 2, 2017
September 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Re-appearance of mutations non detectable after treatment or increase of ctDNA comparing to the nadir
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
Study Arms (1)
Biological sampling in ovarian carcinoma
EXPERIMENTALBlood and tumor samples
Interventions
Eligibility Criteria
You may qualify if:
- Patient with suspicion of ovarian or tubar epithelial cancer, or peritoneal primitive carcino-ma, without previous treatment for ovarian malignancy.
- Indication of preoperative and/or adjuvant chemotherapy.
- Age ≥ 18 years old.
- Patient affiliated to the ''National security'' regimen or beneficiary of this regimen
- Signed written informed consent prior to any screening procedures being performed
- Contraindication to surgical assessment.
- Pathological diagnosis of mucinous carcinoma.
- 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).
- Assessment by the investigator as being unable or unwilling to comply with the require-ments of the protocol.
- Patient in urgency situation, adult under legal protection, or unable to give his consent.
You may not qualify if:
- Any diagnostic that is not ovarian or tubar epithelial cancer, or peritoneal primitive carcinoma.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Paoli-Calmetteslead
- AstraZenecacollaborator
Study Sites (3)
Centre Jean Perrin
Clermont-Ferrand, 63011, France
Centre Oscar Lambret
Lille, 59000, France
Institut Du Cancer de Montpellier
Montpellier, 34298, France
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Renaud SABATIER, MD
Institut Paoli-Calmettes
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2017
First Posted
October 5, 2017
Study Start
October 10, 2018
Primary Completion
October 30, 2023
Study Completion
October 30, 2023
Last Updated
September 26, 2019
Record last verified: 2019-09