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NCT Number: NCT06606366

Study on the Contribution of the Genetic Tumor Profile Obtained by Circulating Tumor DNA Analysis in the Multidisciplinary Molecular Biology Meeting of Eastern PACA

This study will evaluate the diagnostic performance of liquid biopsy for identifying molecular abnormalities among patients managed by the Multidisciplinary Molecular Biology Meeting. The gold standard considered in this study is the solid biopsy.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Antoine Lacassagne

Nice, 06189, France

Location status: Recruiting

Location contact

Esma SAADA-BOUZID

PRINCIPAL_INVESTIGATOR

Study coordinator

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Over 18 years old.
  • Advanced-stage malignant solid tumor managed in a non-curative context.
  • Patient eligible for Multidisciplinary molecular biology meeting with available archived tumor material (frozen or FFPE block, less than 5 years old) or a biopsiable tumor lesion.
  • Patient able to read, write, and understand the French language.
  • Patient has read the information sheet and signed the informed consent.
  • Patient has social security coverage.

Exclusion criteria

  • Previous or concurrent cancer diagnosed or treated within the last 5 years, except for in situ carcinoma of the cervix, basal cell or squamous cell carcinoma of the skin, and adequately treated in situ carcinoma of the bladder.
  • Severe or uncontrolled systemic disease.
  • Any condition which, in the investigator's judgment (geographical, social, or psychological factors, etc.), makes the patient unable to comply with study follow-up and procedures.
  • Patient considered a vulnerable person; vulnerable persons are defined in Articles L1121-5 to L1121-8:
  • Pregnant women, women in labor, and breastfeeding mothers,
  • Persons deprived of liberty by judicial or administrative decision, individuals hospitalized without consent under Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8,
  • Persons admitted to a healthcare or social institution for reasons other than research,
  • Adults unable to give their consent.

Treatment and study plan

Blood sample taken for the liquid biopsy

Procedure

36 mL will be taken for the study.

Primary outcomes

  1. Sensitivity of liquid biopsy versus solid biopsy (gold standard)

    Time frame: 1 month

    The primary endpoind is the sensitivity of liquid biopsy versus solid biopsy as the gold standard for detecting genomic alterations evaluated in the studied gene panel.

    The panel will consist of 70 genes common to the PanoraMix panels (125 genes, FFPE) and Avida (104 genes, cpDNA).

Secondary outcomes

  1. Specificity of liquid biopsy versus solid biopsy (gold standard)

    Time frame: 1 month

    The specificity of liquid biopsy versus solid biopsy as the gold standard in the detection of genomic alterations evaluated in the studied gene panel.

  2. Failure rate of molecular screening

    Time frame: 1 month

    The failure rate of molecular screening (defined as the inability to provide the genetic profile from the liquid biopsy due to technical failure).

  3. Clinical factors predictive of the sensitivity of liquid biopsy.

    Time frame: 1 month

    Clinical factors predictive of the sensitivity of liquid biopsy.

  4. Rate of unexploitable results

    Time frame: 1 month

    The rate of unexploitable results, defined as the rate of results that do not allow for classification for each technique of the results as True Positive, False Positive, False Negative, or True Negative.

  5. Time required to obtain each analysis

    Time frame: 1 month

    The time required to obtain each analysis, defined as the time between the prescription of the test and the delivery of the result.

Study contacts

Contact information is provided by the study sponsor or research team.

Study coordinator

CONTACT

[email protected]

+33 04 92 03 14 76

Sponsors and collaborators

Lead sponsor

Centre Antoine Lacassagne

Other

Registry information

Acronym: TARGET

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 23, 2024
Registry last updated
Jul 20, 2026

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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