Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB 2020-A02872-37 | Other Identifier | ANSM | |
| APHP201461 | Other Identifier | AP-HP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eurofins Biomnis | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects free of malignancy | Experimental | Moderate intensity physical effort and meal (once) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate intensity physical effort | Other | Pedaling 15 minutes at 75 Watt then 100 Watt of the ergometer |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0 minutes (before eating) and 120 minutes after eating |
| Change in circulating DNA induced by moderate effort in patients with colon cancer |
Not provided
Inclusion Criteria:
Subjects free of malignancy
Patients with colon cancer
Exclusion Criteria:
All subjects
Subjects free of malignancy
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annie BERGERA | Contact | 33 1 44 84 17 24 | gestion-locale.drc@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pierre LAURENT-PUIG, MD-PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hôpitaux de Paris, Hôpital européen Georges Pompidou | Paris | Île-de-France Region | 75015 | France |
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Two years after the last publication
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).
Not provided
Not provided
Physiological pilot study-two groups
Not provided
Not provided
Not provided
Not provided
| Low intensity physical effort | Other | Pedaling 3 minutes at the 30 Watt level of the ergometer |
|
| Hyperlipidic meal | Other | Eating an hyperlipidic meal 60 minutes after a physical effort |
|
| Measure of circulating DNA | Diagnostic 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. |
|
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 |
| 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 | 0 minutes (before eating) and 120 minutes after eating |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D001519 | Behavior |
Not provided
Not provided