Molecular Markers in Cancers and Precancers (MOCA)

NCT05257707 | Withdrawn

• 1 other identifier: 2021-A01532-39
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

In oncology, the search for genetic alterations or infectious agents in tumour tissues has become a major medical challenge for diagnosis, prognosis, prediction of response to treatment and in particular to targeted therapies, or for the biological monitoring of the disease. Over the last ten years, the development of new molecular biology tools based on high-throughput technologies has enabled us to revisit our conceptions of the development and natural history of cancers. The use of these tools has also allowed the dismemberment of numerous cancerous pathologies according to their molecular etiologies and oncogenetic histories. These new molecular biology tools have thus contributed to the emergence of so-called personalised or precision medicine.

Conditions

Cancer; Precancerous Lesion; Healthy

Keywords

biomarker; DNA; papillomavirus; mutation

Outcome Measures

Primary Outcomes (4)

• Identification and prevalence of somatic mutations in precancers and cancers

  Somatic mutations will be identified from precancer and cancer tissues from different localisations and from circulating DNA by NGS.

  5 years

• Identification and prevalence epigenetic modifications in precancers and cancers

  DNA methylation patterns will be identified from precancer and cancer tissues from different localisations and from circulating DNA by NGS or methylation specific PCR.

  5 years

• Identification and prevalence of HPV in precancers and cancers

  HPV genotypes will be identified from precancer and cancer tissues from different localisations and from circulating DNA by NGS or multiplex PCR.

  5 years

• Assessment of HPV viral load

  HPV viral load will be assessed from precancer and cancer tissues from different localisations and from circulating DNA by real-time PCR or ddPCR.

  5 years

Study Arms (1)

intervention

EXPERIMENTAL

Diagnostic Test: Molecular biology

Interventions

Molecular biology DIAGNOSTIC_TEST

Samples will be taken as part of routine care consultations. These include * Smears taken with cytobrushes adapted to the anatomical site (cervix, vulva, vagina, penis, anus, upper aerodigestive tract...). * Blood samples taken to isolate plasma, cells or serum. * CSF and effusion samples taken with a suitable puncture needle (lumbar puncture, ascites puncture, pleural puncture, etc.). * Urine samples collected in sterile ECBU jars. * Biopsies taken according to the recommendations of good clinical practice using specific forceps adapted to the anatomical site. * Surgical parts. * Eyebrows. * Saliva samples or gargle samples.

intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients with or without a precancerous lesion or cancer
• Patients covered by a social security plan
• Patients who have given their consent

You may not qualify if:

• Patient in emergency situation
• Contraindication to tissue, cell, blood or other biological fluid collection
• Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU de Besançon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 25, 2022
• Study Start: October 5, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

FR (1)