NCT05147545

Brief Summary

The study of circulating tumoral DNA makes it possible to study, without invasive procedures or pathological studies, the tumoral DNA circulating in the blood of a patient and its various alterations. In patients with colon-rectal cancer with resected tumor, circulating tumor DNA can be used as a predictive biomarker of metastatic relapse of cancer. However, the routine extension of circulating tumoral DNA remains limited due to several difficulties. One of the pifalls that circulating tumor DNA is greatly diluted by healthy circulating DNA from non-tumor cells. The amount of healthy circulating DNA has been described as being influenced by certain physiological parameters. The aim of the study is to increase knowledge on the influence of physiological factors associated with sports activity and meal on the release kinetics of circulating DNA.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 7, 2021

Completed
1.7 years until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

9 months

First QC Date

November 15, 2021

Last Update Submit

April 14, 2023

Conditions

Colon Cancer

Keywords

colon cancercirculating DNAExerciseMeal

Outcome Measures

Primary Outcomes (1)

  • Change in circulating DNA induced by moderate effort in subjects free of malignacy

    Variation in the concentration of circulating DNA between the value measured after 1 hour of rest, during and at recovery of moderate intensity physical effort

    0, 3, 15 minutes of exercise, 15, 30 and 60 minutes of recovery.

Secondary Outcomes (3)

  • Change in circulating DNA induced by hyperlipidic meal in subjects free of malignacy

    0 minutes (before eating) and 120 minutes after eating

  • Change in circulating DNA induced by moderate effort in patients with colon cancer

    0, 15, 30 and 60 minutes of recovery.

  • Change in circulating DNA induced by hyperlipidic meal in patients with colon cancer

    0 minutes (before eating) and 120 minutes after eating

Study Arms (2)

Subjects free of malignancy

EXPERIMENTAL

Moderate intensity physical effort and meal (once)

Other: Moderate intensity physical effortOther: Hyperlipidic mealDiagnostic Test: Measure of circulating DNA

Patients with colon cancer

EXPERIMENTAL

Low intensity physical effort and meal (visit 1, day of cycle 1 chemotherapy) and low intensity physical effort (visit 2, day of cycle 2 chemotherapy)

Other: Low intensity physical effortOther: Hyperlipidic mealDiagnostic Test: Measure of circulating DNA

Interventions

Moderate intensity physical effortOTHER

Pedaling 15 minutes at 75 Watt then 100 Watt of the ergometer

Subjects free of malignancy
Low intensity physical effortOTHER

Pedaling 3 minutes at the 30 Watt level of the ergometer

Patients with colon cancer
Hyperlipidic mealOTHER

Eating an hyperlipidic meal 60 minutes after a physical effort

Patients with colon cancerSubjects free of malignancy
Measure of circulating DNADIAGNOSTIC_TEST

Multiple measure of circulating DNA: on an empty stomach, at the end of the physical effort, after 15, 30 and 60 minutes of rest, 120 minutes after an hyperlipidic meal. An additional measure will occur for subjects free of malignancy during the effort.

Patients with colon cancerSubjects free of malignancy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects free of malignancy
  • men or women 40-70 yrs aged
  • Patients with colon cancer
  • men or women 18-85 yrs aged
  • Biopsy-proven colon cancer with indication to chemiotherapy
  • Chemiotherapy (first line or second line) not started

You may not qualify if:

  • All subjects
  • Ischemic cardiac history
  • known heart disease
  • blood hemoglobin concentration \<8g / dl
  • Acute or chronic systemic illnesses, (apart from diabetes, essential or secondary hypertension for patients)
  • Pregnancy or breastfeeding or in progress
  • Subjects free of malignancy
  • Cardiovascular risk factor (active smoking or greater than 10 pack-years, diabetes, hypertension or known dyslipidemia not controlled by the diet)
  • Glomerular filtration rate estimated by the CKD epi (Chronic Kidney Disease - Epidemiology Collaboration) formula \< 60 ml.min-1.1.73 m-²
  • Contraindication to exercise
  • Drug taking in progress (except estrogen-progestogen contraception)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Paris, Hôpital européen Georges Pompidou

Paris, Île-de-France Region, 75015, France

Location

MeSH Terms

Conditions

Colonic NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesBehavior

Study Officials

  • Pierre LAURENT-PUIG, MD-PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annie BERGERA

CONTACT

33 1 44 84 17 24gestion-locale.drc@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Physiological pilot study-two groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2021

First Posted

December 7, 2021

Study Start

September 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Two years after the last publication
Access Criteria
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared Supporting Information: Study Protocol Informed Consent Form (ICF) Time Frame: Two years after the last publication Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR(1)