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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 February 2024 |
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Main ID: |
NCT01350908 |
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Date of registration:
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06/05/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Circulating Tumoral DNA in Ovarian Cancer
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Scientific title:
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Development and Validation of a Circulating Tumor DNA Detection Technique in Patients With Ovarian Cancer |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT01350908 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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LANTZ Olivier, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut Curie |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age > or = 18 years.
- Patient with invasive ovarian cancer stage II to IV from FIGO classification.
- Patient treated by surgery.
- Patient with tumor or metastasis available for TP53 status characterization
- Patient able to stand a blood collection.
- Signed written informed consent approved by AFSSAPS and CPP.
Exclusion Criteria:
- Patient without social protection / insurance.
- Borderline ovarian tumor.
- Non carcinoma ovarian tumor
- Patient with invasive ovarian cancer 5 years before diagnosis
- Current pregnancy and lactation.
- All social, medical, psychological, situations making the study impossible.
- Person deprived of liberty.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Ovarian Cancer
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Intervention(s)
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Other: Blood sampling
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Primary Outcome(s)
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Assessment and development of circulating tumor DNA detection techniques
[Time Frame: 2 years]
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Secondary Outcome(s)
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Comparison of the detection techniques (PAP (pyrophosphorolysis activated polymerisation), BEAMing, NGS(Next sequencing generation) with regards to feasibility, robustness, sensitivity and cost.
[Time Frame: 2 years]
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Secondary ID(s)
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IC2010-03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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