Immunophenotyping of Metastases From Colorectal Cancer

November 19, 2020 updated by: Istituto Oncologico Veneto IRCCS

Immune therapy represents a promising option for the treatment of an increasing number of malignancies. New immunotherapeutic strategies are currently under development and will be further studied starting from refractory settings of heavily pre-treated mCRC patients. On this basis, a specific immunological characterization of CRC metastasis will be relevant to direct future clinical and pharmacological research.

As surgery is a therapeutic option in the treatment of mCRC, a percentage of mCRC patients undergo to resection of metastasis before or after medical treatment. These tumour samples could be useful to define the immune signature of colorectal metastatic disease.

On the basis of the above reported considerations, an exploratory, prospective, observational study for the immunophenotypical characterization of colorectal cancer metastasis from pre-treated vs chemo-naive patients has been planned.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

  • There is extensive evidence for molecular heterogeneity in CRC. Studies have revealed that intra-tumour heterogeneity can be highly variable within primary tumours or between primary and metastatic sites (1). Moreover, tumour heterogeneity can be linked to targeted therapies in terms of acquired resistance mutations (2). In the era of precision medicine, specific molecular characterization of primary tumour and metastasis taking into account the dynamism of the disease and the actual therapeutic target should be considered.
  • Nowadays there is not enough information regarding the immunological characterization of CRC metastasis. Especially, few data are available about the effect of chemotherapy and targeted drugs on the interplay between tumour and the immune system of the host (3).
  • Immune system takes part to different phases of tumour growth (4). It is a dynamic balance that can be differentially modulated by several agents, resulting in immunosuppression or immunostimulation. Becht et al. integrated the molecular classification of colorectal cancer with information about their immune microenvironment. They identified 2 "immune-high subgroups". The MSI-rich CMS1 group is characterized by an immune stimulating contexture while the mesenchymal CMS4 group has an immune suppressive microenvironment (5). No data regarding the evolution over time of these features are available so far.
  • Immune therapy represents a promising option for the treatment of an increasing number of malignancies. New immunotherapeutic strategies are currently under development and will be further studied starting from refractory settings of heavily pre-treated mCRC patients. On this basis, a specific immunological characterization of CRC metastasis will be relevant to direct future clinical and pharmacological research.
  • As surgery is a therapeutic option in the treatment of mCRC, a percentage of mCRC patients undergo to resection of metastasis before or after medical treatment. These tumour samples could be useful to define the immune signature of colorectal metastatic disease.

On the basis of the above reported considerations, an exploratory, prospective, observational study is planned for the immunophenotypical characterization of colorectal cancer metastasis from pre-treated vs chemo-naive patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Padova, Italy, 35128
        • Istituto Oncologico Veneto IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Pre-treated or chemo-naive patients with resected CRC metastasis

Description

Inclusion Criteria:

  • Histological diagnosis of colorectal cancer
  • Metastatic disease
  • Surgery for metastatic disease
  • Availability of clinical data

Exclusion Criteria:

  • Non-metastatic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
chemo-naive patients
pre-treated patients with systemic chemotherapy +/- a targeted

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
immunological features of metastasis
Time Frame: through study completion, an average of 1 year
Tumor-infiltrating lymphocytes (TIL)
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Oncologico Veneto IRCCS

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Azienda Ospedaliera di Padova
Azienda ULSS 16 Padova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Take five

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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