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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Antoine Lacassagne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Pregnant women, women in labor, and breastfeeding mothers,

Trial design

Design model

Single group

Treatments tested in this trial

  • Blood sample taken for the liquid biopsy

    Procedure/Surgery

    36 mL will be taken for the study.

Treatment groups

238 Participants
are divided into 1 treatment group
Group A: ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Sensitivity of liquid biopsy versus solid biopsy (gold standard)

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).

Time frame
1 month

Secondary outcomes

1

Specificity of liquid biopsy versus solid biopsy (gold standard)

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

Time frame
1 month
2

Failure rate of molecular screening

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

Time frame
1 month
3

Clinical factors predictive of the sensitivity of liquid biopsy.

Clinical factors predictive of the sensitivity of liquid biopsy.

Time frame
1 month
4

Rate of unexploitable results

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.

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.