MelanomaMSNNCT02105168
Identification of Marker of Primary or Acquired Resistance to Anti Tumorous Treatment
A study testing Blood sample, Tumorous biopsy and Healthy material sample in people with Melanoma and Non Small Cell Lung Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
Lung Cancer and melanoma relapsed frequently whereas its very sensitive to treatment such as chemotherapy or radiotherapy. The purpose of this study is to have a better understanding of why those patients are relapsing using next generation sequencing to identify rare mutations and assessed their predictive value. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Non Small Cell Lung Cancer, Small Cell Lung Cancer
- What is being tested?
- Blood sample, Tumorous biopsy and Healthy material sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2009to Jul 2019
- 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
- Cytological or histological diagnosis of SCLC, NSCLC or melanoma
- Patients age >/= 18 years old
- Indication of treatment using platinum salts for lung cancer except for patient with NSCLC treated by surgery for whom platinum salts is not indicated
- If a biopsy is proposed, lesion lust be easily accessible
- Signed informed consent
Who cannot join
- Patients unable to follow the protocol
- Consent refusal
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val de Marne, 94805
Benjamin Besse, MD, 0142114317 ext. +33, benjamin.besse@gustaveroussy.fr
Caroline Robert, MD
About this study
Official title: Identification of Marker of Primary or Acquired Resistance to Anti Tumorous Treatment in Patients With Lung Cancer or Melanoma
Lung Cancer and melanoma relapsed frequently whereas its very sensitive to treatment such as chemotherapy or radiotherapy. The purpose of this study is to have a better understanding of why those patients are relapsing using next generation sequencing to identify rare mutations and assessed their predictive value.
- Conditions
- Melanoma, Non Small Cell Lung Cancer, Small Cell Lung Cancer
- Being tested
- Blood sample, Tumorous biopsy, Healthy material sample
- Medical subject headings
- Melanoma, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleProcedure or surgery
Optional
Tumorous biopsyProcedure or surgery
Optional
Healthy material sampleProcedure or surgery
Optional
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Blood sample Tumorous biopsy Healthy material sample Receives: Procedure: Blood sample; Procedure: Tumorous biopsy; Procedure: Healthy material sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mutation rate on tumorous material
Assessed at the time of inclusion using tumorous material used for diagnosis
Measured: Assessed at the time of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startJul 2009
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Besse, MD, Study chair, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105168
- Sponsor's protocol ID
- 2008-A00373-52
- Other IDs
- 2007/1363
- Acronym
- MSN
- Status last verified
- Jun 2016
- First submitted
- 31 Mar 2014
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Mezquita L, Preeshagul I, Auclin E, Saravia D, Hendriks L, Rizvi H, Park W, Nadal E, Martin-Romano P, Ruffinelli JC, Ponce S, Audigier-Valette C, Carnio S, Blanc-Durand F, Bironzo P, Tabbo F, Reale ML, Novello S, Hellmann MD, Sawan P, Girshman J, Plodkowski AJ, Zalcman G, Majem M, Charrier M, Naigeon M, Rossoni C, Mariniello A, Paz-Ares L, Dingemans AM, Planchard D, Cozic N, Cassard L, Lopes G, Chaput N, Arbour K, Besse B. Predicting immunotherapy outcomes under therapy in patients with advanced NSCLC using dNLR and its early dynamics. Eur J Cancer. 2021 Jul;151:211-220. doi: 10.1016/j.ejca.2021.03.011. Epub 2021 May 19.
PubMed 34022698
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Marker of Primary or Acquired Resistance to Anti Tumorous Treatment in Patients With Lung Cancer or Melanoma
- ClinicalTrials.gov ID
- NCT02105168
- Acronym / sponsor ID
- MSN / 2008-A00373-52
- Conditions
- Melanoma, Non Small Cell Lung Cancer, Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 7 Apr 2014 (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.
Lung Cancer and melanoma relapsed frequently whereas its very sensitive to treatment such as chemotherapy or radiotherapy. The purpose of this study is to have a better understanding of why those patients are relapsing using next generation sequencing to identify rare mutations and assessed their predictive value.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Procedure: Blood sample, Procedure: Tumorous biopsy, Procedure: Healthy material sampleBlood sample Tumorous biopsy Healthy material sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cytological or histological diagnosis of SCLC, NSCLC or melanoma
- Patients age >/= 18 years old
- Indication of treatment using platinum salts for lung cancer except for patient with NSCLC treated by surgery for whom platinum salts is not indicated
- If a biopsy is proposed, lesion lust be easily accessible
- Signed informed consent
Key exclusion criteria (2 listed)
- Patients unable to follow the protocol
- Consent refusal
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 sampleOptional | Procedure or surgery | Experimental arm |
| Tumorous biopsyOptional | Procedure or surgery | Experimental arm |
| Healthy material sampleOptional | Procedure or surgery | Experimental arm |
Primary outcome
Mutation rate on tumorous material
Time frame: Assessed at the time of inclusion
Assessed at the time of inclusion using tumorous material used for diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
- Derived from this study: PubMed 34022698Mezquita L, Preeshagul I, Auclin E, Saravia D, Hendriks L, Rizvi H, Park W, Nadal E, Martin-Romano P, Ruffinelli JC, Ponce S, Audigier-Valette C, Carnio S, Blanc-Durand F, Bironzo P, Tabbo F, Reale ML, Novello S, Hellmann MD, Sawan P, Girshman J, Plodkowski AJ, Zalcman G, Majem M, Charrier M, Naigeon M, Rossoni C, Mariniello A, Paz-Ares L, Dingemans AM, Planchard D, Cozic N, Cassard L, Lopes G, Chaput N, Arbour K, Besse B. Predicting immunotherapy outcomes under therapy in patients with advanced NSCLC using dNLR and its early dynamics. Eur J Cancer. 2021 Jul;151:211-220. doi: 10.1016/j.ejca.2021.03.011. Epub 2021 May 19.
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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.
Benjamin Besse, MD study chair
Gustave Roussy, Cancer Campus, Grand Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample, Tumorous biopsy and Healthy material sample in people with Melanoma and Non Small Cell Lung Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Besse, MD (0142114317 ext. +33, benjamin.besse@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mutation rate on tumorous material (time frame: Assessed at the time of inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02105168, which also lists 1 linked publication.
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 10 Jun 2016.