NCT02701907

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

36 active sites

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

First Submitted

Initial submission to the registry

January 27, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2022

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

4.4 years

First QC Date

January 27, 2016

Last Update Submit

September 5, 2022

Conditions

Metastatic Cancers

Outcome Measures

Primary Outcomes (1)

  • 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

    42 months

Secondary Outcomes (2)

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

    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

    42 months

Study Arms (6)

breast cancer

OTHER

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

non-small cell lung cancer

OTHER

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

kidney cancer

OTHER

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

colorectal cancer

OTHER

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

ovarian cancer

OTHER

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

skin cutaneous melanoma

OTHER

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

Interventions

Blood samplingOTHER
breast cancercolorectal cancerkidney cancernon-small cell lung cancerovarian cancerskin cutaneous melanoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pediatric patient (\<18 years old at diagnosis).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (36)

Clinique de l'Europe

Amiens, France

Location

CHU d'Angers

Angers, France

Location

Institut de Cancérologie de l'Ouest (site Paul Papin)

Angers, France

Location

Centre Hospitalier Annecy Genevois (CHANGE) - site d'Annecy

Annecy, France

Location

CHU d'Auxerre

Auxerre, France

Location

Institut Sainte-Catherine

Avignon, France

Location

Centre Hospitalier de la Côte Basque

Bayonne, France

Location

Institut Bergonié

Bordeaux, France

Location

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, France

Location

Hôpital Privé Sainte Marie

Chalon-sur-Saône, France

Location

Centre Hospitalier Metropole Savoie

Chambéry, France

Location

Centre Jean Perrin

Clermont-Ferrand, France

Location

CH Sud Francilien

Corbeil, France

Location

Centre Georges-François Leclerc

Dijon, France

Location

Hôpital Privé Drôme Ardèche - Clinique Pasteur

Guilherand-Granges, France

Location

Centre Oscar Lambret

Lille, France

Location

CH de Longjumeau

Longjumeau, France

Location

Centre Léon Bérard

Lyon, France

Location

Hôpital Privé Jean Mermoz

Lyon, France

Location

Hôpital Nord

Marseille, France

Location

Institut Paoli-Calmettes

Marseille, France

Location

Hôpital Clinique Claude Bernard

Metz, France

Location

Institut de Cancérologie de Lorraine

Nancy, France

Location

Institut de Cancérologie de l'Ouest (site René Gauducheau)

Nantes, France

Location

Centre Antoine Lacassagne

Nice, France

Location

CHR d'Orléans - Hôpital de la Source

Orléans, France

Location

Curie Paris

Paris, France

Location

Hôpital Européen Georges Pompidou (HEGP)

Paris, France

Location

Hôpital Saint Louis

Paris, France

Location

Centre Hospitalier Lyon Sud - Hospices Civils de Lyon

Pierre-Bénite, France

Location

CHU de Poitiers - Pôle régional de Cancérologie

Poitiers, France

Location

Centre Eugène Marquis

Rennes, France

Location

Hôpitaux Drôme-Nord- Site de Romans sur Isère

Romans-sur-Isère, France

Location

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, France

Location

Institut Claudius Regaud

Toulouse, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Charles Ferté, MD PhD

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2016

First Posted

March 8, 2016

Study Start

December 1, 2016

Primary Completion

April 17, 2021

Study Completion

April 17, 2022

Last Updated

September 7, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(36)