Study of Circulating Tumoral DNA in Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01350908
• Other study ID #: IC2010-03
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: December 2015

Study information

• Verified date: January 2024
• Source: Institut Curie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Institut Curie	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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