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

Primary Purpose

Metastatic Cancers

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metastatic Cancers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinique de l'Europe
  • CHU d'Angers
  • Institut de Cancérologie de l'Ouest (site Paul Papin)
  • Centre Hospitalier Annecy Genevois (CHANGE) - site d'Annecy
  • CHU d'Auxerre
  • Institut Sainte-Catherine
  • Centre Hospitalier de la Côte Basque
  • Institut Bergonié
  • Polyclinique Bordeaux Nord Aquitaine
  • Hôpital Privé Sainte Marie
  • Centre Hospitalier Metropole Savoie
  • Centre Jean Perrin
  • CH Sud Francilien
  • Centre Georges-François Leclerc
  • Hôpital Privé Drôme Ardèche - Clinique Pasteur
  • Centre Oscar Lambret
  • CH de Longjumeau
  • Centre Léon Bérard
  • Hôpital Privé Jean Mermoz
  • Hôpital Nord
  • Institut Paoli-Calmettes
  • Hôpital Clinique Claude Bernard
  • Institut de Cancérologie de Lorraine
  • Institut de Cancérologie de l'Ouest (site René Gauducheau)
  • Centre Antoine Lacassagne
  • CHR d'Orléans - Hôpital de la Source
  • Curie Paris
  • Hôpital Européen Georges Pompidou (HEGP)
  • Hôpital Saint Louis
  • Centre Hospitalier Lyon Sud - Hospices Civils de Lyon
  • CHU de Poitiers - Pôle régional de Cancérologie
  • Centre Eugène Marquis
  • Hôpitaux Drôme-Nord- Site de Romans sur Isère
  • Institut de Cancérologie de la Loire
  • Institut Claudius Regaud
  • Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Other

Other

Other

Other

Other

Other

Arm Label

breast cancer

non-small cell lung cancer

kidney cancer

colorectal cancer

ovarian cancer

skin cutaneous melanoma

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The secondary endpoint is the rate of tumors with low level of genomic alterations between the EXPRESS cohort and control cohorts of patients.
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

Full Information

First Posted
January 27, 2016
Last Updated
September 5, 2022
Sponsor
UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT02701907
Brief Title
EXPRESS: EXcePtional RESponSe - Exceptional and Unexpected Response to Targeted Therapies
Acronym
EXPRESS
Official Title
Low Level of Genomic Alteration to Predict Exceptional and Unexpected Response to Targeted Therapies in Patients With Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
April 17, 2021 (Actual)
Study Completion Date
April 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancers

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
breast cancer
Arm Type
Other
Arm Description
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
Arm Title
non-small cell lung cancer
Arm Type
Other
Arm Description
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
Arm Title
kidney cancer
Arm Type
Other
Arm Description
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
Arm Title
colorectal cancer
Arm Type
Other
Arm Description
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
Arm Title
ovarian cancer
Arm Type
Other
Arm Description
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
Arm Title
skin cutaneous melanoma
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Blood sampling
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patient ( ≥18 years old at diagnosis). Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses. 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. Metastatic or locally advanced disease. 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. 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. 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. Availability of normal tissue along with the tumor tissue, otherwise blood sample in order to extract constitutional DNA. Exclusion Criteria: Pediatric patient (<18 years old at diagnosis). Hematological malignancy or solid tumors, which are not in the scope of tumor types described in the inclusion criteria. Tumor sample not available or not reaching the required quality for whole exome sequencing analysis. Absence of confirmation of the exceptional and unexpected pattern of response by the college of experts as defined above.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Ferté, MD PhD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique de l'Europe
City
Amiens
Country
France
Facility Name
CHU d'Angers
City
Angers
Country
France
Facility Name
Institut de Cancérologie de l'Ouest (site Paul Papin)
City
Angers
Country
France
Facility Name
Centre Hospitalier Annecy Genevois (CHANGE) - site d'Annecy
City
Annecy
Country
France
Facility Name
CHU d'Auxerre
City
Auxerre
Country
France
Facility Name
Institut Sainte-Catherine
City
Avignon
Country
France
Facility Name
Centre Hospitalier de la Côte Basque
City
Bayonne
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
Country
France
Facility Name
Polyclinique Bordeaux Nord Aquitaine
City
Bordeaux
Country
France
Facility Name
Hôpital Privé Sainte Marie
City
Chalon-sur-Saône
Country
France
Facility Name
Centre Hospitalier Metropole Savoie
City
Chambéry
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
Country
France
Facility Name
CH Sud Francilien
City
Corbeil
Country
France
Facility Name
Centre Georges-François Leclerc
City
Dijon
Country
France
Facility Name
Hôpital Privé Drôme Ardèche - Clinique Pasteur
City
Guilherand-Granges
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
Country
France
Facility Name
CH de Longjumeau
City
Longjumeau
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
Country
France
Facility Name
Hôpital Privé Jean Mermoz
City
Lyon
Country
France
Facility Name
Hôpital Nord
City
Marseille
Country
France
Facility Name
Institut Paoli-Calmettes
City
Marseille
Country
France
Facility Name
Hôpital Clinique Claude Bernard
City
Metz
Country
France
Facility Name
Institut de Cancérologie de Lorraine
City
Nancy
Country
France
Facility Name
Institut de Cancérologie de l'Ouest (site René Gauducheau)
City
Nantes
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
Country
France
Facility Name
CHR d'Orléans - Hôpital de la Source
City
Orléans
Country
France
Facility Name
Curie Paris
City
Paris
Country
France
Facility Name
Hôpital Européen Georges Pompidou (HEGP)
City
Paris
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
Country
France
Facility Name
Centre Hospitalier Lyon Sud - Hospices Civils de Lyon
City
Pierre-Bénite
Country
France
Facility Name
CHU de Poitiers - Pôle régional de Cancérologie
City
Poitiers
Country
France
Facility Name
Centre Eugène Marquis
City
Rennes
Country
France
Facility Name
Hôpitaux Drôme-Nord- Site de Romans sur Isère
City
Romans-sur-Isère
Country
France
Facility Name
Institut de Cancérologie de la Loire
City
Saint Priest en Jarez
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
Country
France
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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