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An Experimental Medicine Clinical Study to Compare Peripheral Immune System From Subjects Without Cancer Diagnosis and Patients With Solid Tumours. (IMMUNOPBMC)

Servier Protocol Code: 2021-A01796-35 Sponsor: Servier Clinicaltrials.gov Identifier: NCT05133128

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How to participate to the study?
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you don’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 2 locations

Study description

The immune system (made of organs, certain blood cells, proteins and other substances) is designed to defend the body against foreign or dangerous invaders including abnormal cells. In some cases, abnormal cells can escape the control of the immune system. This may lead to the development of cancer. At this stage, the immune system may be prevented from functioning properly by the tumour itself to promote the growth of the cancer. It is therefore important to understand what goes wrong with the immune system to discover new treatments for cancer.

This study was done to gain knowledge on components of the immune system from persons without cancer diagnosis and persons with cancer. The participants did not receive any treatment as part of this study. The main aim of the study was to find out if the levels of certain immune system components (called immune profile) are similar between participants without cancer and those with advanced solid tumour cancer. Solid tumour cancers are abnormal growths of cells in organ(s) of the body such as the lung, liver, or colon. In advanced stages of disease, solid tumours may spread in the body.

Official title: An Experimental Medicine, Low Grade Interventional, Clinical Study to Compare Peripheral Immune System From Subjects Without Cancer Diagnosis and Patients With Advanced Solid Tumours
Results
Conditions
Immune System
Interventions / Treatments
  • blood samples
Other study id numbers
  • 2021-A01796-35

Eligibility Criteria

Eligible age for the study

45 years to 70 years (Adult, Older Adult)

Sexes

Male/Female

Accepts Healthy Volunteers

Yes

To take part, participants had to:

  • Be 45 to 70 years of age.
  • Belong to one of the 4 groups:
  • For group 1
    • Have a specific type of lung cancer called non-small cell lung cancer.
  • For group 2
    • Have colorectal cancer. Colorectal cancer is a cancer that starts in the large bowel and involves the rectum (the lowest part of the gut).
  • For group 3
    • Have cancer of the pancreas (the organ lying behind the lower part of the stomach that produces digestive substances and certain chemical substances called hormones).
  • For group 6
    • Be an individual without cancer diagnosis.

Due to difficulties to find new participants, the 2 optional groups planned (group 4 and group 5) were not opened.

 

Participants could not take part in the study if:

  • They had received anticancer treatment with drugs or radiation within 14 days before starting the study.
  • They had received drugs that affect how the immune system works (called immunomodulators) within 6 months before starting the study.

How is the study designed?

Allocation
N/A
Interventional study model
Single Group
Participant Group / Arm
Other: Participants with non-small cell lung cancer
Intervention / Treatment
Other: Blood samples
Participant Group / Arm
Other: Participants with colorectal cancer
Intervention / Treatment
Other: Blood samples
Participant Group / Arm
Other: Participants with pancreatic cancer
Intervention / Treatment
Other: Blood samples
Participant Group / Arm
Other: Participants with liver cancer
Intervention / Treatment
Other: Blood samples
Participant Group / Arm
Other: Participants with gastric cancer/cholangiocarcinoma
Intervention / Treatment
Other: Blood samples
Participant Group / Arm
Other: Healthy volunteers
Intervention / Treatment
Other: Blood samples

Keywords

Provided by Servier
PBMC cancer
Additional Relevant MeSH Terms Glioma
Neoplasms