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

September 5, 2022 updated by: UNICANCER

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • Clinique de l'Europe
      • Angers, France
        • CHU d'Angers
      • Angers, France
        • Institut de Cancérologie de l'Ouest (site Paul Papin)
      • Annecy, France
        • Centre Hospitalier Annecy Genevois (CHANGE) - site d'Annecy
      • Auxerre, France
        • CHU d'Auxerre
      • Avignon, France
        • Institut Sainte-Catherine
      • Bayonne, France
        • Centre Hospitalier de la Cote Basque
      • Bordeaux, France
        • Institut Bergonie
      • Bordeaux, France
        • Polyclinique Bordeaux Nord Aquitaine
      • Chalon-sur-Saône, France
        • Hopital Prive Sainte Marie
      • Chambéry, France
        • Centre Hospitalier Metropole Savoie
      • Clermont-Ferrand, France
        • Centre Jean Perrin
      • Corbeil, France
        • CH Sud Francilien
      • Dijon, France
        • Centre Georges-Francois Leclerc
      • Guilherand-Granges, France
        • Hôpital privé Drôme Ardèche - Clinique Pasteur
      • Lille, France
        • Centre Oscar Lambret
      • Longjumeau, France
        • CH de Longjumeau
      • Lyon, France
        • Centre Leon Berard
      • Lyon, France
        • Hopital privé Jean Mermoz
      • Marseille, France
        • Institut Paoli-Calmettes
      • Marseille, France
        • Hopital Nord
      • Metz, France
        • Hopital Clinique Claude Bernard
      • Nancy, France
        • Institut de Cancérologie de Lorraine
      • Nantes, France
        • Institut de Cancérologie de l'Ouest (site René Gauducheau)
      • Nice, France
        • Centre Antoine Lacassagne
      • Orléans, France
        • CHR D'Orleans - Hopital de la Source
      • Paris, France
        • Hôpital Saint Louis
      • Paris, France
        • Hôpital Européen Georges Pompidou (HEGP)
      • Paris, France
        • Curie Paris
      • Pierre-Bénite, France
        • Centre Hospitalier Lyon Sud - Hospices Civils de Lyon
      • Poitiers, France
        • CHU de Poitiers - Pôle Régional de Cancérologie
      • Rennes, France
        • Centre Eugene Marquis
      • Romans-sur-Isère, France
        • Hôpitaux Drôme-Nord- Site de Romans sur Isère
      • Saint Priest en Jarez, France
        • Institut de Cancerologie de La Loire
      • Toulouse, France
        • Institut Claudius Regaud
      • Villejuif, France, 94805
        • Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult patient ( ≥18 years old at diagnosis).
  2. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.
  3. Patient suffering from the following tumor type: breast cancer, lung adenocarcinoma or squamous cell carcinoma, colorectal cancer, ovarian cancer, renal clear cell cancer, skin cutaneous melanoma.
  4. Metastatic or locally advanced disease.
  5. Currently or previously treated with an anticancer targeted therapy in monotherapy. Targeted therapies combined with other agents are accepted only if 1/ the tumor was previously proven to be progressive under the same agents or 2/ the response or the stability has been maintained with the targeted therapy alone after the agent has been stopped.
  6. Exceptional and unexpected tumor response to any marketed targeted therapy confirmed by the college of experts and defined as: complete response or partial response lasting more than six months, and not expected in more than 10% of the patients in this drug organ situation.
  7. Availability and required quality of the tumor biopsy (FFPE or frozen sample) allowing for the whole exome sequencing analysis. Tumor biopsies obtained just before the initiation of the targeted therapy are preferred; otherwise any prior sample is possible.
  8. Availability of normal tissue along with the tumor tissue, otherwise blood sample in order to extract constitutional DNA.

Exclusion Criteria:

  1. Pediatric patient (<18 years old at diagnosis).
  2. Hematological malignancy or solid tumors, which are not in the scope of tumor types described in the inclusion criteria.
  3. Tumor sample not available or not reaching the required quality for whole exome sequencing analysis.
  4. Absence of confirmation of the exceptional and unexpected pattern of response by the college of experts as defined above.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: breast cancer
In this study, we aim to assess whether tumors characterized by a low level of genomic alterations (mutation, amplification or deletion) are associated with unexpected and exceptional responses across targeted anticancer therapies. We will focus our analyses on tumor types for which molecular targeted anticancer agents are frequently prescribed
Other: Blood sampling
OTHER: non-small cell lung cancer

In this study, the investigators aim to assess whether tumors characterized by a low level of genomic alterations (mutation, amplification or deletion) are associated with unexpected and exceptional responses across targeted anticancer therapies.

The investigators will focus analyses on tumor types for which molecular targeted anticancer agents are frequently prescribed
Other: Blood sampling
OTHER: kidney cancer
In this study, the investigators aim to assess whether tumors characterized by a low level of genomic alterations (mutation, amplification or deletion) are associated with unexpected and exceptional responses across targeted anticancer therapies. the investigators will focus analyses on tumor types for which molecular targeted anticancer agents are frequently prescribed
Other: Blood sampling
OTHER: colorectal cancer
In this study, the investigators aim to assess whether tumors characterized by a low level of genomic alterations (mutation, amplification or deletion) are associated with unexpected and exceptional responses across targeted anticancer therapies. the investigators will focus analyses on tumor types for which molecular targeted anticancer agents are frequently prescribed
Other: Blood sampling
OTHER: ovarian cancer
In this study, the investigators aim to assess whether tumors characterized by a low level of genomic alterations (mutation, amplification or deletion) are associated with unexpected and exceptional responses across targeted anticancer therapies. the investigators will focus analyses on tumor types for which molecular targeted anticancer agents are frequently prescribed
Other: Blood sampling
OTHER: skin cutaneous melanoma
In this study, the investigators aim to assess whether tumors characterized by a low level of genomic alterations (mutation, amplification or deletion) are associated with unexpected and exceptional responses across targeted anticancer therapies. the investigators will focus analyses on tumor types for which molecular targeted anticancer agents are frequently prescribed
Other: Blood sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 42 months
42 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary endpoint is the rate of tumors with low level of genomic alterations between the EXPRESS cohort and control cohorts of patients.
Time Frame: 42 months
42 months
Exploratory analyses will be performed to compare the profiles between the EXPRESS and the control cohorts of patients, to identify novel candidate somatic molecular profiles
Time Frame: 42 months
42 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Investigators

  • Principal Investigator: Charles Ferté, MD PhD, Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2016

Primary Completion (ACTUAL)

April 17, 2021

Study Completion (ACTUAL)

April 17, 2022

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

March 2, 2016

First Posted (ESTIMATE)

March 8, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 5, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UC-0105/1508
  • 2015-A01500-49 (REGISTRY: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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