Immunological Profile of Solid Tumors Sample

NCT03311100 — Unknown, 1040 participants, Assistance Publique Hopitaux De Marseille

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

Registry	NCT03311100
Status	Unknown
Study type	Observational
Enrollment	1040 (Estimated)
Sponsor	Assistance Publique Hopitaux De Marseille (Other); collaborators: Innate Pharma
Conditions	Solid Cancer
Interventions	immunohistochemistry assay (Other)
Dates	start 2017-04-06, primary completion 2019-04-06 (estimated), completion 2020-04-06 (estimated), first posted 2017-10-16, last updated 2018-01-30
Locations	1 site in France

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Lung cancer		Other: immunohistochemistry assay
Central Nervous System Cancers		Other: immunohistochemistry assay
Head and Neck and upper aero-digestive tract cancers		Other: immunohistochemistry assay
Skin cancers		Other: immunohistochemistry assay
Sarcomas		Other: immunohistochemistry assay
Urothelial cancer		Other: immunohistochemistry assay
Hepatocarcinoma		Other: immunohistochemistry assay

immunohistochemistry assay (Other): biomarkers expression

+Outcome measures

Primary outcomes

Immunohistochemistry scores [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)
Immunohistochemistry scores [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

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Assistance Publique Hôpitaux de Marseille	Marseille	France	Recruiting

+Investigators

ARNAUD Jean-Olivier, Director, Study director, Assistance Publique Hôpitaux de Marseille