Back to resultsStudy of Circulating Tumoral DNA in Ovarian Cancer
Primary Purpose
Ovarian Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
About this trial
This is an interventional other trial for Ovarian Cancer
Eligibility Criteria
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.
Sites / Locations
- Institut Curie
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Blood sampling
Arm Description
Outcomes
Primary Outcome Measures
Assessment and development of circulating tumor DNA detection techniques
Quantification of circulating tumor DNA in blood samples. Results expressed in number of samples where circulating DNA is present.
Secondary Outcome Measures
Comparison of the detection techniques (PAP (pyrophosphorolysis activated polymerisation), BEAMing, NGS(Next sequencing generation) with regards to feasibility, robustness, sensitivity and cost.
The methods of detection which will be used such as the BEAMing, the PAP(pyrophosphorolysis activated polymerization) and the NGS(next sequencing generation is techniques of a big specificity capable of detecting a mutant copy among 1.104 wild copies for the BEAMing, 2.109 for the PAP and 1.105 for the NGS. The sensibility of these techniques is limited by the quantity of genomic DNA which we can extract from the sample of blood.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01350908
Brief Title
Study of Circulating Tumoral DNA in Ovarian Cancer
Official Title
Development and Validation of a Circulating Tumor DNA Detection Technique in Patients With Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Curie
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Circulating tumor DNA detection and quantification in patients with ovarian cancer.
Detailed Description
Technique development:
In a first step, the different available techniques will be evaluated for specificity and sensibility using serial dilutions of cell lines with or without TP53 mutation.
Validation:
The tumor DNA detection rate will be estimated from patient's blood with ovarian cancer.
The investigators will study 25 patients to obtain at least 15 patients bearing a TP53 mutation that could be characterized in the primitive tumor or metastasis. With those 15 patients, the investigators will determine the most sensitive technique and the best cost/efficiency ratio.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blood sampling
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Blood sampling
Intervention Description
30mL of peripherical blood will be collected specially for the study. It's an additional blood sampling compare to the normal follow up of the patient.
Primary Outcome Measure Information:
Title
Assessment and development of circulating tumor DNA detection techniques
Description
Quantification of circulating tumor DNA in blood samples. Results expressed in number of samples where circulating DNA is present.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Comparison of the detection techniques (PAP (pyrophosphorolysis activated polymerisation), BEAMing, NGS(Next sequencing generation) with regards to feasibility, robustness, sensitivity and cost.
Description
The methods of detection which will be used such as the BEAMing, the PAP(pyrophosphorolysis activated polymerization) and the NGS(next sequencing generation is techniques of a big specificity capable of detecting a mutant copy among 1.104 wild copies for the BEAMing, 2.109 for the PAP and 1.105 for the NGS. The sensibility of these techniques is limited by the quantity of genomic DNA which we can extract from the sample of blood.
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LANTZ Olivier, MD
Organizational Affiliation
Institut Curie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study of Circulating Tumoral DNA in Ovarian Cancer
We'll reach out to this number within 24 hrs