Metastatic CancersEXPRESSNCT02701907
EXPRESS: EXcePtional RESponSe - Exceptional and Unexpected Response to Targeted Therapies
A study testing Blood sampling in people with Metastatic Cancers, run by UNICANCER at 36 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancers
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 36 sitesFrance
- Study dates
- Dec 2016to 17 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
France36 sites
Clinique de l'Europe
Amiens
CHU d'Angers
Angers
Institut de Cancérologie de l'Ouest (site Paul Papin)
Angers
Centre Hospitalier Annecy Genevois (CHANGE) - site d'Annecy
Annecy
CHU d'Auxerre
Auxerre
Institut Sainte-Catherine
Avignon
Centre Hospitalier de la Côte Basque
Bayonne
Institut Bergonié
Bordeaux
Polyclinique Bordeaux Nord Aquitaine
Bordeaux
Hôpital Privé Sainte Marie
Chalon-sur-Saône
Centre Hospitalier Metropole Savoie
Chambéry
Centre Jean Perrin
Clermont-Ferrand
CH Sud Francilien
Corbeil
Centre Georges-François Leclerc
Dijon
Hôpital Privé Drôme Ardèche - Clinique Pasteur
Guilherand-Granges
Centre Oscar Lambret
Lille
CH de Longjumeau
Longjumeau
Centre Léon Bérard
Lyon
Hôpital Privé Jean Mermoz
Lyon
Hôpital Nord
Marseille
Institut Paoli-Calmettes
Marseille
Hôpital Clinique Claude Bernard
Metz
Institut de Cancérologie de Lorraine
Nancy
Institut de Cancérologie de l'Ouest (site René Gauducheau)
Nantes
Centre Antoine Lacassagne
Nice
CHR d'Orléans - Hôpital de la Source
Orléans
Curie Paris
Paris
Hôpital Européen Georges Pompidou (HEGP)
Paris
Hôpital Saint Louis
Paris
Centre Hospitalier Lyon Sud - Hospices Civils de Lyon
Pierre-Bénite
CHU de Poitiers - Pôle régional de Cancérologie
Poitiers
Centre Eugène Marquis
Rennes
Hôpitaux Drôme-Nord- Site de Romans sur Isère
Romans-sur-Isère
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez
Institut Claudius Regaud
Toulouse
Gustave Roussy
Villejuif, 94805
About this study
Official title: 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.
Read the 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
- Being tested
- Blood sampling
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startDec 2016
- Primary completion17 Apr 2021
- Study completion17 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancersStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Ferté, MD PhD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701907
- Sponsor's protocol ID
- UC-0105/1508
- Other IDs
- 2015-A01500-49
- Acronym
- EXPRESS
- Status last verified
- Sep 2022
- First submitted
- 27 Jan 2016
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Level of Genomic Alteration to Predict Exceptional and Unexpected Response to Targeted Therapies in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT02701907
- Acronym / sponsor ID
- EXPRESS / UC-0105/1508
- Conditions
- Metastatic Cancers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 17 Apr 2021 (actual)
- Study completion
- 17 Apr 2022 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| breast cancer | Other | Other: Blood samplingIn 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 |
| non-small cell lung cancer | Other | Other: Blood samplingIn 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 |
| kidney cancer | Other | Other: Blood samplingIn 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 |
| colorectal cancer | Other | Other: Blood samplingIn 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 |
| ovarian cancer | Other | Other: Blood samplingIn 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 |
| skin cutaneous melanoma | Other | Other: Blood samplingIn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling | Other | breast cancer, colorectal cancer, kidney cancer, non-small cell lung cancer, ovarian cancer, skin cutaneous melanoma |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- EXPRESS Study - websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Metastatic Cancers
RecruitingPhase 3
A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
IO Resistant Squamous and Nonsquamous NSCLC
RecruitingPhase 2
A Clinical Study on Prophylactic RespOnse To hEtrombopag for Secondary Prevention in Anti-Cancer Therapy-induced Thrombocytopeniae
Breast Cancer Patients at High Risk of Chemotherapy-induced Thrombocytopenia (CTIT)
Not yet recruitingPhase 1
A Study of Mesothelin-Targeted CAR-Mix Cells in Patients With Advanced Solid Tumors
Mesothelin-Positive Advanced Solid Tumors With Peritoneal Metastasis
Not yet recruitingPhase 2
Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer
Breast Cancer, Advanced Breast Cancer
RecruitingPhase 2
Phase 2 Trial of Zanzalintinib and Pembrolizumab in Select Subtypes of Advanced/Metastatic Soft-tissue Sarcoma
Phase 2, Zanzalintinib
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Ferté, MD PhD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Metastatic Cancers, run by UNICANCER at 36 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.