Immunological Profile of Solid Tumors Sample
Study of the Immunological Profile of Archival Formalin-fixed Paraffin-embedded Solid Tumors Sample
2 other identifiers
observational
1,040
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 6, 2017
CompletedFirst Submitted
Initial submission to the registry
October 11, 2017
CompletedFirst Posted
Study publicly available on registry
October 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 6, 2020
CompletedJanuary 30, 2018
January 1, 2018
2 years
October 11, 2017
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
Central Nervous System Cancers
Head and Neck and upper aero-digestive tract cancers
Skin cancers
Sarcomas
Urothelial cancer
Hepatocarcinoma
Interventions
biomarkers expression
Eligibility Criteria
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
- Assistance Publique Hopitaux De Marseillelead
- Innate Pharmacollaborator
Study Sites (1)
Assistance Publique Hôpitaux de Marseille
Marseille, 13354, France
Biospecimen
Samples in formalin-fixed paraffin-embedded material block
Study Officials
- STUDY DIRECTOR
ARNAUD Jean-Olivier, Director
Assistance Publique Hôpitaux de Marseille
Central Study Contacts
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