Skip to main content
OpenTrials
Completed

NCT Number: NCT02813928

Diagnostic and Prognosis Value of Circulating DNA for CRC Patients' Surveillance After Curative Treatment

Inspite of curative treatment 30-50% patients with ColoRectal Cancer (CRC) develop tumor relapse during the first 3 years after treatment of the primary tumor. Treatment of relapses is based on surgical resection, when possible, chemotherapy and targeted therapies. To detect recurrences or metastases, a surveillance strategy is recommended for patients able to withstand complementary treatment during a five-year period. Over this period, the probability of one false-positive result is 87%. Considering that less than 10% of recurrent patients are suitable for potentially curative treatment and that more intensive programs enable an increase of the overall rate of curative resection but do not result in reduced mortality, less time and cost-consuming, tailored follow-up is necessary. The level of circulating ccfDNA, defined as extra cellular DNA, increases in CRC patients. The Inplex® method could validate the use of ccfDNA as a cancer biomarker in terms of prognosis and surveillance.

Tubes for ccfDNA analysis will be taken during medical examination at the same time of the CEA dosage (if it was not made before the consultation). Cryotubes of plasma will be sent for analysis in the laboratory INSERM (National Health Institute) of Montpellier and the remaining plasma will be kept in biological collection.

Patients will have a consultation of follow-up every 3-4 months during which the dosage of CEA and ccfDNA will be realized as well as a medical examination, a general examination (weight, size, and blood pressure), an evaluation of the indices of performance status and a nutritional evaluation in case of loss of weight.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aurillac Hospital, Aurillac, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 years
  • Primary diagnosis of stages II and III CRC:
  • is already operated and histological proven (biopsy at least)
  • is patient that must be operated: curative treatment for stages II and III CRC
  • Patient benefiting from a program personalized by care
  • Written informed consent

Exclusion criteria

  • Patient already treated for stages II and III CRC and in surveillance
  • Patient with indication or with palliative treatment
  • Pregnant or nursing patients
  • Known pregnancy
  • Difficulties to understand the protocol
  • Patients under protection measure (guardianship, curatorship, protection of justice)

Treatment and study plan

ccfDNA analysis

Genetic

The level of circulating ccfDNA, defined as extra cellular DNA, increases in CRC patients. The Inplex® method could validate the use of ccfDNA as a cancer biomarker in terms of prognosis and surveillance

Primary outcomes

  1. The presence of recurrences detected for patients curatively treated for a CRC stages II and III within the 3 years of follow-up.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: ADNCirc

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Jun 27, 2016
Registry last updated
Aug 2, 2022

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.

Published trials that share one or more normalized conditions with this study.