Study of Circulating Tumoral DNA in Ovarian Cancer

Development and Validation of a Circulating Tumor DNA Detection Technique in Patients With Ovarian Cancer

Circulating tumor DNA detection and quantification in patients with ovarian cancer.

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer
• Intervention / Treatment: Other: Blood sampling

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75005
    • Institut Curie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Blood sampling	Other: Blood sampling; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Collaborators and Investigators

• Sponsor: Institut Curie
• Investigators: Principal Investigator: LANTZ Olivier, MD, Institut Curie

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: May 6, 2011
• First Submitted That Met QC Criteria: May 9, 2011
• First Posted (Estimated): May 10, 2011

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: IC2010-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months.
• IPD Sharing Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP