Colon CancerASRHACOLSNCT05147545
Impact of Exercise and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects
A study testing Moderate intensity physical effort, Low intensity physical effort and Hyperlipidic meal in people with Colon Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Moderate intensity physical effort, Low intensity physical effort and Hyperlipidic meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2023to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Paris, Hôpital européen Georges Pompidou
Paris, Île-de-France Region, 75015
Pierre LAURENT-PUIG, MD-PHD, 331 76 53 43 81, pierre.laurent-puig@aphp.fr
About this study
Official title: Impact of Sport Practice and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects. Physiological Pilot Study
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.
Read the detailed description
20 subjects free of malignancy (Male-Female Ratio 2 to 1) the variation in the concentration of DNA circulating between the value measured on an empty stomach after 1 hour of rest, then at the end of each of the successive stages of moderate intensity physical effort: pedaling 15 minutes at 75 Watt then 100 Watt of the ergometer. Dosages will be repeated after 15, 30 and 60 minutes of recovery. After an hour of recovery, the subject will be asked to consume a meal rich in fat. The circulating DNA will be measured 2 hours after the end of the meal.
40 patients with colon cancer will be enrolled for a two visit study. The first visit will be planned at the first cycle of chemotherapy, before the chemotherapy. At this visit, the influence of exercise on plasma concentrations of circulating free DNA will also be studied in 40 patients with colon cancer. Free circulating DNA will be measured on an empty stomach after 1 hour of rest, then immediately after low-intensity physical effort : pedaling 3 minutes at the 30 Watt level of the ergometer) and after 15, 30 and 60 minutes of recovery. After an hour of recovery, the subject will be proposed to consume a meal rich in fat. The circulating DNA will be measured 2 hours after the end of the meal. The second visit will be planned at the first second of chemotherapy, before the chemotherapy. Free circulating DNA will be measured on an empty stomach after 1 hour of rest, then immediately after low-intensity physical effort : pedaling 3 min at the 30 Watt level of the ergometer, and after 15, 30 and 60 minutes of recovery.
- Conditions
- Colon Cancer
- Being tested
- Moderate intensity physical effort, Low intensity physical effort, Hyperlipidic meal, Measure of circulating DNA
- Keywords
- colon cancer, circulating DNA, Exercise, Meal
- Medical subject headings
- Colonic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate intensity physical effortOther
Pedaling 15 minutes at 75 Watt then 100 Watt of the ergometer
Low intensity physical effortOther
Pedaling 3 minutes at the 30 Watt level of the ergometer
Hyperlipidic mealOther
Eating an hyperlipidic meal 60 minutes after a physical effort
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects free of malignancy | Experimental | Moderate intensity physical effort and meal (once) Receives: Other: Moderate intensity physical effort; Other: Hyperlipidic meal; Diagnostic 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) Receives: Other: Low intensity physical effort; Other: Hyperlipidic meal; Diagnostic Test: Measure of circulating DNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Variation in the concentration of circulating DNA between the value measured before and after an hyperlipidic meal in subjects free of malignancy
Measured: 0 minutes (before eating) and 120 minutes after eating
Change in circulating DNA induced by moderate effort in patients with colon cancer
Variation in the concentration of circulating DNA between the value measured after 1 hour of rest, during and at recovery of low intensity physical effort
Measured: 0, 15, 30 and 60 minutes of recovery.
Change in circulating DNA induced by hyperlipidic meal in patients with colon cancer
Variation in the concentration of circulating DNA between the value measured before and after an hyperlipidic meal
Measured: 0 minutes (before eating) and 120 minutes after eating
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study startSep 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Physiological pilot study-two groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Eurofins Biomnis
- Responsible party
- Sponsor
- Investigators
- Pierre LAURENT-PUIG, MD-PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147545
- Sponsor's protocol ID
- APHP201461
- Other IDs
- IDRCB 2020-A02872-37, APHP201461
- Acronym
- ASRHACOLS
- Status last verified
- Apr 2023
- First submitted
- 15 Nov 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sport Practice and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects. Physiological Pilot Study
- ClinicalTrials.gov ID
- NCT05147545
- Acronym / sponsor ID
- ASRHACOLS / APHP201461
- Conditions
- Colon Cancer
- Keywords
- colon cancer, circulating DNA, Exercise, Meal
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Eurofins Biomnis
- Study start
- Sep 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 7 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
20 subjects free of malignancy (Male-Female Ratio 2 to 1) the variation in the concentration of DNA circulating between the value measured on an empty stomach after 1 hour of rest, then at the end of each of the successive stages of moderate intensity physical effort: pedaling 15 minutes at 75 Watt then 100 Watt of the ergometer. Dosages will be repeated after 15, 30 and 60 minutes of recovery. After an hour of recovery, the subject will be asked to consume a meal rich in fat. The circulating DNA will be measured 2 hours after the end of the meal.
40 patients with colon cancer will be enrolled for a two visit study. The first visit will be planned at the first cycle of chemotherapy, before the chemotherapy. At this visit, the influence of exercise on plasma concentrations of circulating free DNA will also be studied in 40 patients with colon cancer. Free circulating DNA will be measured on an empty stomach after 1 hour of rest, then immediately after low-intensity physical effort : pedaling 3 minutes at the 30 Watt level of the ergometer) and after 15, 30 and 60 minutes of recovery. After an hour of recovery, the subject will be proposed to consume a meal rich in fat. The circulating DNA will be measured 2 hours after the end of the meal. The second visit will be planned at the first second of chemotherapy, before the chemotherapy. Free circulating DNA will be measured on an empty stomach after 1 hour of rest, then immediately after low-intensity physical effort : pedaling 3 min at the 30 Watt level of the ergometer, and after 15, 30 and 60 minutes of recovery.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Physiological pilot study-two groups
| Arm | Type | Receives |
|---|---|---|
| Subjects free of malignancy | Experimental | Other: Moderate intensity physical effort, Other: Hyperlipidic meal, Diagnostic Test: Measure of circulating DNAModerate intensity physical effort and meal (once) |
| Patients with colon cancer | Experimental | Other: Low intensity physical effort, Other: Hyperlipidic meal, Diagnostic Test: Measure of circulating DNALow intensity physical effort and meal (visit 1, day of cycle 1 chemotherapy) and low intensity physical effort (visit 2, day of cycle 2 chemotherapy) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects free of malignancy
- Patients with colon cancer
Key exclusion criteria (11 listed)
- All subjects
- Subjects free of malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate intensity physical effortPedaling 15 minutes at 75 Watt then 100 Watt of the ergometer | Other | Subjects free of malignancy |
| Low intensity physical effortPedaling 3 minutes at the 30 Watt level of the ergometer | Other | Patients with colon cancer |
| Hyperlipidic mealEating an hyperlipidic meal 60 minutes after a physical effort | Other | Patients with colon cancer, Subjects free of malignancy |
| Measure of circulating DNAMultiple 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. | Diagnostic test | Patients with colon cancer, Subjects free of malignancy |
Primary outcome
Change in circulating DNA induced by moderate effort in subjects free of malignacy
Time frame: 0, 3, 15 minutes of exercise, 15, 30 and 60 minutes of recovery.
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
3 secondary outcomes
Change in circulating DNA induced by hyperlipidic meal in subjects free of malignacy
Time frame: 0 minutes (before eating) and 120 minutes after eating
Change in circulating DNA induced by moderate effort in patients with colon cancer
Time frame: 0, 15, 30 and 60 minutes of recovery.
Change in circulating DNA induced by hyperlipidic meal in patients with colon cancer
Time frame: 0 minutes (before eating) and 120 minutes after eating
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre LAURENT-PUIG, MD-PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate intensity physical effort, Low intensity physical effort and Hyperlipidic meal in people with Colon Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annie BERGERA (33 1 44 84 17 24, gestion-locale.drc@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in circulating DNA induced by moderate effort in subjects free of malignacy (time frame: 0, 3, 15 minutes of exercise, 15, 30 and 60 minutes of recovery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.