Study and Modulation of Immune Responses in Primary and Metastatic Colon Cancers

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

Colorectal cancer (CRC) is the 3rd most common cancer in France. Treatment of CRC relies primarily on surgical removal of the primary tumor and chemotherapy is the current standard of care for synchronous metastatic disease. Overall survival remains strongly correlated with the tumor stage at the time of surgery, from 90% at five years for localized disease (stages 1 and 2), to around 20% for metastatic forms of the disease (stage 4). Recent research in cancer highlights the role of the immune system in the development, evolution and fate of tumors. Understanding the nature of interactions between different immune cells infiltrating the tumor is important for the development of innovative therapies. Recently, the consensus molecular classification of CRC confirmed the importance of the immune response in CRC by showing that a "high immune response" is a good prognostic indicator for patients with this pathology. However, immunotherapies are effective for only a minority of patients with metastatic CRC. Indeed, anti Programmed cell Death 1 (anti-PD-1), -PD-L1 immune checkpoint blocking antibodies have only shown effectiveness in patients with microsatellite instability (MSI), which only represents 5% of metastatic CRCs.

Thus, the aim of this study is to better understand the role of the immune system on the development of CRC and its possible modulation to treat or prevent metastatic recurrences.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female 18 years of age or older

Diagnosis of colorectal adenocarcinoma

Scheduled resection of tumor and/or metastasis(es)

Disqualifiers

Patient's opposition to research

Patients under guardianship

The following situations

Persons unable to understand and/or read the information leaflet

Trial population

Patients undergoing surgery for the treatment of primary and/or metastatic colorectal cancers

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Sampling

    Other intervention

    Blood and surgical specimen sampling the day of surgery

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Patients undergoing surgery for the treatment of primary and/or metastatic colorectal cancers1 intervention

Trial outcomes

Primary outcomes

1

Effectiveness of immunotherapies in a co-culture model

Characterize effective immunotherapies in colorectal cancers by demonstrating their effectiveness in a co-culture model between cancer cells and autologous T cells.

Time frame
At 1 year

Secondary outcomes

1

Evaluation of transcriptomic differences

Evaluation of transcriptomic differences between tissues or cells from the healthy mucosa compared to those from the primary or metastatic tumor: sequencing of mRNA in the two types of mucosa and comparison of mRNA expression profiles between the latter.

Time frame
At 5 years
2

Evaluation of proteomic differences

Evaluation of proteomic differences between tissues or cells from the healthy mucosa in comparison to those from the primary tumor by: multiplexed immunodetection in situ in tissues detection and dosage of proteins in culture supernatants (ELISA), in a co-culture model between cancer cells and autologous T cells, with or without modulation of a pathway targeting the T lymphocyte response by immunotherapy.

Time frame
At 5 years
3

Evaluation of the T Cell Receptor (TCR) repertoire

Evaluation of the TCR repertoire by sequencing, carried out from: patient blood, DNA from cancerous tissues and healthy mucosa DNA from the co-culture between cancer cells and autologous T cells, with or without modulation of a pathway targeting the T lymphocyte response by immunotherapy

Time frame
At 5 years

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: