CClinicalTrials.gg
Status unknownNCT03311100Updated Jan 30, 2018

Immunological Profile of Solid Tumors Sample

An observational study in Solid Cancer, sponsored by Assistance Publique Hopitaux De Marseille. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-30.

Sponsored by Assistance Publique Hopitaux De Marseille · Observational

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,040
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Solid Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with solid cancer

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

Exclusion Criteria:

  • Samples from subject unwilling to give their informed consent;
  • Unusable sample or biologically deteriorated.
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,040 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

Interventions

  • Otherimmunohistochemistry assay

    biomarkers expression

05

What researchers measure

Primary outcomes

  1. 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) 1. : \< 10 % stained cell (minimal) 2. : 10 to 50 % (mild) 3. : 51 to 79 % (moderate) 4. : = or \> 80 % (marked)

    Time frame: 24 months

  2. Immunohistochemistry scores

    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

    Time frame: 24 months

06

Study locations

1 of 1 sites recruiting
  • Assistance Publique Hôpitaux de Marseille
    Marseille, 13354, France
    Recruiting
07

Registry details

Key details

Study ID
NCT03311100
Lead sponsor
Assistance Publique Hopitaux De Marseille
Collaborators
Innate Pharma
Responsible party
Sponsor
First posted
Oct 16, 2017
Start date
Apr 6, 2017
Primary completion
Apr 6, 2019 (estimated)
Completion
Apr 6, 2020 (estimated)
Last update
Jan 30, 2018

Study contacts

BARLESI Fabrice, PU-PH
Contact
fabrice.barlesi@ap-hm.fr
491385590 ext. +33
ARNAUD Jean-Olivier, Director
study director · Assistance Publique Hôpitaux de Marseille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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