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Completed

NCT Number: NCT01350908

Study of Circulating Tumoral DNA in Ovarian Cancer

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

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Curie

Paris, 75005, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sampling

Other

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 outcomes

  1. Assessment and development of circulating tumor DNA detection techniques

    Time frame: 2 years

    Quantification of circulating tumor DNA in blood samples. Results expressed in number of samples where circulating DNA is present.

Secondary outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
May 10, 2011
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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