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Trial record 10 of 208 for:    circulating dna | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT02813928
Recruitment Status : Recruiting
First Posted : June 27, 2016
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Genetic: ccfDNA analysis Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnostic and Prognosis Value of Circulating DNA for CRC Patients' Surveillance After Curative Treatment
Study Start Date : July 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ccfDNA analysis
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.
Genetic: ccfDNA analysis
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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813928


Contacts
Contact: Muriel MATHONNET, MD +33 5 55 05 67 13 mathonnet@unilim.fr

Locations
France
Limoges Hospital Recruiting
Limoges, France, 87 042
Contact: Muriel MATHONNET, MD         
Sponsors and Collaborators
University Hospital, Limoges

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT02813928     History of Changes
Other Study ID Numbers: I15031
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: the data are anonymized

Keywords provided by University Hospital, Limoges:
ColoRectal Cancer
Cancerology
Translational Research
ccfDNA

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases