NCT03311100

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,040

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2020

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

October 11, 2017

Last Update Submit

January 29, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

    24 months

  • 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

    24 months

Study Arms (7)

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

biomarkers expression

Central Nervous System CancersHead and Neck and upper aero-digestive tract cancersHepatocarcinomaLung cancerSarcomasSkin cancersUrothelial cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with solid cancer

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples in formalin-fixed paraffin-embedded material block

Study Officials

  • ARNAUD Jean-Olivier, Director

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR

Central Study Contacts

BARLESI Fabrice, PU-PH

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2017

First Posted

October 16, 2017

Study Start

April 6, 2017

Primary Completion

April 6, 2019

Study Completion

April 6, 2020

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations