NCT01865045

Brief Summary

This is a multicenter retrospective analysis .The aim of the present study is to investigate the molecular predictors of vinorelbine response in tumor samples of a series of MPM patients and evaluate the possible impact on clinical outcome. Sample size: around 150 patients based on the availability of tumor size

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2013

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 10, 2022

Status Verified

September 1, 2022

Enrollment Period

4.1 years

First QC Date

May 27, 2013

Last Update Submit

September 8, 2022

Conditions

Malignant Pleural Mesothelioma

Outcome Measures

Primary Outcomes (1)

  • Expression of TUBB3 and BRCA1 in MPM tumor tissue by immunohistochemistry and RT-PCR.

    2 months

Secondary Outcomes (1)

  • Association of expression of TUBB3 and BRCA1 with clinical outcome (response, survival) .

    2 months

Study Arms (1)

no treatment

no treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Malignant pleural mesothelioma patients treated with vinorelbine as a second or later line chemotherapy with at least an objective response evaluation.

You may qualify if:

  • MPM patients treated with vinorelbine in the ≥ second line setting will be retrospectively analyzed
  • Patients will be selected based on the availability of tumor tissue

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

tissue

MeSH Terms

Conditions

Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

MesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, MesothelialLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SitePleural NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • armando santoro, MD

    Istituto Clinico Humanitas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 27, 2013

First Posted

May 30, 2013

Study Start

November 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

September 10, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

not planned

Locations

IT(1)