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OpenTrials
Completed

NCT Number: NCT02608346

Circulating Tumor DNA and Follow-up of BRCA1 Mutation Carriers (CirCa 01)

BRCA1 carriers who are at high risk of developing either a relapse and/or a new cancer growth will be included. These patients will be followed up during 30 months (2,5 years) with mutated TP53 mutation detection or during 42 months (3,5 years) with mutated TP53 mutation detection and circulating tumor cells detection (CTC) performed at each hospital visit (for technical reason only patients included at Institut Curie will be proposed to participate to the CTC substudy).

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Key information

Conditions

Women With BRCA1 Germline Deleterious Mutation Neoplasm Metastasis Neoplasms Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Léon Bérard, Lyon, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient with no evidence of any invasive tumor mass at inclusion (clinical and, if any, radiological exams)
  • Carriers of known germline BRCA1 deleterious mutation (a personal history of cancer is NOT mandatory).
  • Age ≥ 30 years for patient with personal previous history of cancer
  • Age ≥ 40 years for patient without personal previous history of cancer
  • Patient who a follow-up visit is scheduled in the including center at least once a year
  • Patient having health care insurance
  • Signed informed consent by patient

Exclusion criteria

  • Patient presenting with invasive tumor masses (e.g. stage IV cancer or localized cancer not yet surgically removed)
  • Carriers of germline BRCA1 variant of unknown significance
  • Carriers of germline BRCA2 deleterious mutation or variant
  • Individuals with a low risk of BRCA1-related tumor growth, i.e. women who underwent prophylactic bilateral mastectomy AND adnexectomy.
  • Any medical or other condition that in the Investigator's opinion rendered the patient unsuitable for this study
  • Patient deprived from ability to decide on her own.
  • Patient unable to have a regular follow up for geographical, social or psychological reasons.

Treatment and study plan

blood sampling

Procedure

Patients will have a blood draw at each visit to the hospital,

  • with a maximum of 1 blood draw every 3 months, in absence of any abnormal clinical/radiological exam
  • with a maximum of 1 blood draw every week, in case of abnormal clinical/radiological exam that requires further investigation

Primary outcomes

  1. Sensitivity of plasma TP53 mutation detection as a test to detect any tumor growth (relapse and/or new tumor) during the follow-up of women known to carry BRCA1 germline mutation

    Time frame: Up to 42 months

    Sensitivity = % of patients with detectable levels of mutated TP53 ctDNA among those who experience a new tumor growth (relapse and/or new tumor).

  2. Specificity of plasma TP53 mutation detection as a test to detect any tumor growth (relapse and/or new tumor) during the follow-up of women known to carry BRCA1 germline mutation

    Time frame: Up to 42 months

    Specificity = % of patients with undetectable levels of mutated TP53 ctDNA among those who don't experience a new tumor growth (diagnosed within 6 months after the blood draw).

Secondary outcomes

  1. Positive predictive value for mutated TP53 ctDNA

    Time frame: Up to 42 months

    Positive predictive value = Probability of having a tumor growth (relapse and/or new tumor) when mutated TP53 ctDNA is detectable.

  2. Negative predictive value for mutated TP53 ctDNA

    Time frame: Up to 42 months

    Negative predictive value = Probability of being without tumor growth when mutated TP53 ctDNA is not detectable.

  3. Sensitivity of circulating tumor cells detection as a test to detect any tumor growth (relapse and/or new tumor) during the follow-up of women known to carry BRCA1 germline mutation

    Time frame: Up to 42 months

    Sensitivity = % of patients with detectable levels of circulating tumor cells among those who experience a new tumor growth (relapse and/or new tumor).

  4. Specificity of circulating tumor cells detection as a test to detect any tumor growth (relapse and/or new tumor) during the follow-up of women known to carry BRCA1 germline mutation

    Time frame: Up to 42 months

    Specificity = % of patients with undetectable levels of circulating tumor cells among those who don't experience a new tumor growth (diagnosed within 6 months after the blood draw).

  5. Positive predictive value for circulating tumor cells

    Time frame: Up to 42 months

    Positive predictive value = Probability of having a tumor growth (relapse and/or new tumor) when circulating tumor cells is detectable.

  6. Negative predictive value for circulating tumor cells

    Time frame: Up to 42 months

    Negative predictive value = Probability of being without tumor growth when circulating tumor cells is not detectable.

Sponsors and collaborators

Lead sponsor

Institut Curie

Other

Registry information

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2015
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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