Immunological Profile of Solid Tumors Sample

Solid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03311100
• Other study ID #: 2016-53
• Secondary ID: 2017-A00778-45
• Status: Recruiting
• Phase: N/A
• First received: October 11, 2017
• Last updated: January 29, 2018
• Start date: April 6, 2017
• Est. completion date: April 6, 2020

Study information

• Verified date: January 2018
• Source: Assistance Publique Hopitaux De Marseille
• Contact: BARLESI Fabrice, PU-PH
• Phone: 491385590
• Email: fabrice.barlesi[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1040
• Est. completion date: April 6, 2020
• Est. primary completion date: April 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Solid Cancer

Intervention

Other:
• immunohistochemistry assay
biomarkers expression

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille	Innate Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunohistochemistry scores	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); : < 10 % stained cell (minimal); : 10 to 50 % (mild); : 51 to 79 % (moderate); : = or > 80 % (marked)	24 months
Primary	Immunohistochemistry scores	The immunohistochemistry scores is evaluated with the score of the staining intensity.; Staining Intensity: from 0 to 3 0 : no staining (absence); : low staining; : middle staining; : high staining	24 months