Immunological Profile of Solid Tumors Sample

January 29, 2018 updated by: Assistance Publique Hopitaux De Marseille

Study of the Immunological Profile of Archival Formalin-fixed Paraffin-embedded Solid Tumors Sample

It has become clear in the recent year that the nature of the immune cells infiltrate within a tumor was essential in the control of the tumor growth. This so-called immune contexture does vary between cancer types and in response to treatments. In this context, this trial is a non-interventional, mono-centric in patients with solid tumors. Samples in paraffin-embedded material block of biopsies or surgical pieces (either primitive tumor or metastases) will be analysed. For each sample, clinically relevant data associated with treated cancer and needed for characterization of tumor microenvironment will be documented.

This trial is, through accessing to well documented selected archival tumor materials, to validate selected biomarker for early phase trial.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1040

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

  • France
      • Marseille, France, 13354
        • Recruiting
        • Assistance Publique Hopitaux de Marseille
        • Contact:

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

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with solid cancer

Description

Inclusion Criteria:

  • Sample must have had a valid written informed consent for available archival tumor samples for scientific purposes.
  • Sample from patients with histologically documented cancer in target population.

Exclusion Criteria:

  • Samples from subject unwilling to give their informed consent;
  • Unusable sample or biologically deteriorated.

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: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lung cancer
Other: immunohistochemistry assay
biomarkers expression
Central Nervous System Cancers
Other: immunohistochemistry assay
biomarkers expression
Head and Neck and upper aero-digestive tract cancers
Other: immunohistochemistry assay
biomarkers expression
Skin cancers
Other: immunohistochemistry assay
biomarkers expression
Sarcomas
Other: immunohistochemistry assay
biomarkers expression
Urothelial cancer
Other: immunohistochemistry assay
biomarkers expression
Hepatocarcinoma
Other: immunohistochemistry assay
biomarkers expression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunohistochemistry scores
Time Frame: 24 months

The immunohistochemistry scores is evaluated with the score of the percentage of stained cells.

Scale of the score of the percentage of stained cells, From 0 to 4, 0 : no stained cell (absence)

  1. : < 10 % stained cell (minimal)
  2. : 10 to 50 % (mild)
  3. : 51 to 79 % (moderate)
  4. : = or > 80 % (marked)
24 months
Immunohistochemistry scores
Time Frame: 24 months

The immunohistochemistry scores is evaluated with the score of the staining intensity.

Staining Intensity: from 0 to 3 0 : no staining (absence)

  1. : low staining
  2. : middle staining
  3. : high staining
24 months

Collaborators and Investigators

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

Sponsor

Assistance Publique Hopitaux De Marseille

Collaborators

Innate Pharma

Investigators

  • Study Director: ARNAUD Jean-Olivier, Director, Assistance Publique Hopitaux de Marseille

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)

April 6, 2017

Primary Completion (Anticipated)

April 6, 2019

Study Completion (Anticipated)

April 6, 2020

Study Registration Dates

First Submitted

October 11, 2017

First Submitted That Met QC Criteria

October 11, 2017

First Posted (Actual)

October 16, 2017

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 29, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-53
  • 2017-A00778-45 (Registry Identifier: ID RCB)

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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