NCT02701907

EXPRESS: EXcePtional RESponSe - Exceptional and Unexpected Response to Targeted Therapies

Low Level of Genomic Alteration to Predict Exceptional and Unexpected Response to Targeted Therapies in Patients With Solid Tumors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Adult patients with metastatic or locally advanced solid malignancies (including but not limited to breast, cancer, lung adenocarcinoma or squamous cell carcinoma, colorectal cancer, ovarian cancer, renal clear cell cancer, skin cutaneous melanoma), presenting or having presented an exceptional and unexpected response to an antineoplastic targeted therapy.

Detailed description

The primary endpoint is the rate of patients with tumors harboring a low level of genomic alteration (mutation, amplification or deletion) in genes (i.e. mutation, amplification, deletion) identified as causally implicated in cancer. A low level of genomic alteration is defined by the presence of less than the 5th quantile of genomic alterations to be expected in the given tumor type. Conversely, a high level of genomic alteration is defined by the presence of more than the 5th quantile of genomic alterations to be expected in the given tumor type. The list of genes for which alterations are identified as causally implicated in cancer is defined by the Cancer Gene Census. This is an ongoing effort to catalogue those genes for which mutations, amplifications or deletions have been causally implicated in cancer. It is constantly updated by the Wellcome Trust Sanger Institute (UK) and available at: http://cancer.sanger.ac.uk/census (n=571 genes in September 2015)

Conditions

• Metastatic Cancers

Interventions

Type	Name	Description
OTHER	Blood sampling

Timeline

• Start date: 2016-12-01
• Primary completion: 2021-04-17
• Completion: 2022-04-17
• First posted: 2016-03-08
• Last updated: 2022-09-07

Locations

36 sites across 1 country: France