Stage IIIb and IV Non Small Cell Lung CancerANTiCIPeNCT02169349
Molecular Diagnosis on Circulating Tumor DNA of Non-Small Cell Lung Cancer
An observational study of Stage IIIb and IV Non Small Cell Lung Cancer, run by Rennes University Hospital at 1 site in France.
Trial summary
The purpose of this study is to develop an ultra sensitive assay of mutation detection on circulating tumor DNA (ctDNA) for treatment, diagnosis and monitoring disease progression of Non-Small Cell Lung Cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IIIb and IV Non Small Cell Lung Cancer
- What is being tested?
- laboratory biomarker analysis, Next Generation Sequencing and DNA Analysis
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Sep 2016
- Phase
- Observational
- 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
Study population: Participants will be recruited from patients receiving treatment for NSCLC at the Rennes Hospital
Who may be able to join
- Signed written informed consent
- Male or female aged >= 18 years
- Stage IIIb and IV Non Small Cell Lung Cancer histologically confirmed
Who cannot join
- Tissue and plasma samples can not be provided for mutation analysis
- Unwilling or unable to provide informed consent
- Any serious medical condition that would interfere with the subject's safety
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Advancing Monitoring of NSCLC Treated With Epidermal Growth Factor Receptor (EGFR)-Tyrosine Kinase Inhibitor (TKI) - Molecular Diagnosis on Circulating Tumor DNA
The purpose of this study is to develop an ultra sensitive assay of mutation detection on circulating tumor DNA (ctDNA) for treatment, diagnosis and monitoring disease progression of Non-Small Cell Lung Cancer (NSCLC).
- Being tested
- laboratory biomarker analysis, Next Generation Sequencing, DNA Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
Next Generation SequencingOther
DNA AnalysisGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
Mutation profiling of circulating tumor DNA from plasma samples.
To evaluate the sensitivity of NGS to detect the genetic alterations in plasma tumor DNA.
Measured: 1 year
Secondary outcomes (1)
Quantity of circulating tumor DNA in serially collected plasma specimens.
To evaluate the change of quantity of circulating tumor DNA during treatment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IIIb and IV Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Jean Mosser, PUPH, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169349
- Sponsor's protocol ID
- 2014-A00426-41
- Acronym
- ANTiCIPe
- Status last verified
- Oct 2015
- First submitted
- 4 Jun 2014
- Last updated
- 12 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Monitoring of NSCLC Treated With Epidermal Growth Factor Receptor (EGFR)-Tyrosine Kinase Inhibitor (TKI) - Molecular Diagnosis on Circulating Tumor DNA
- ClinicalTrials.gov ID
- NCT02169349
- Acronym / sponsor ID
- ANTiCIPe / 2014-A00426-41
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 23 Jun 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.
The purpose of this study is to develop an ultra sensitive assay of mutation detection on circulating tumor DNA (ctDNA) for treatment, diagnosis and monitoring disease progression of Non-Small Cell Lung Cancer (NSCLC).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from patients receiving treatment for NSCLC at the Rennes Hospital
Key inclusion criteria (3 listed)
- Signed written informed consent
- Male or female aged >= 18 years
- Stage IIIb and IV Non Small Cell Lung Cancer histologically confirmed
Key exclusion criteria (3 listed)
- Tissue and plasma samples can not be provided for mutation analysis
- Unwilling or unable to provide informed consent
- Any serious medical condition that would interfere with the subject's safety
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 |
|---|---|---|
| laboratory biomarker analysis | Other | – |
| Next Generation Sequencing | Other | – |
| DNA Analysis | Genetic | – |
Primary outcome
Mutation profiling of circulating tumor DNA from plasma samples.
Time frame: 1 year
To evaluate the sensitivity of NGS to detect the genetic alterations in plasma tumor DNA.
1 secondary outcome
Quantity of circulating tumor DNA in serially collected plasma specimens.
Time frame: 1 year
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 12 Sep 2016.
Related trials for Stage IIIb and IV Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 3
Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer
Advanced Lung Non-Squamous Non-Small Cell Carcinoma, Metastatic Lung Non-Squamous Non-Small Cell Carcinoma
Active, not recruitingPhase 3
Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer
Lung Non-Squamous Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8
RecruitingPhase 2
A Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Non Small Cell Lung Cancer, Advanced Non Small Cell Lung Cancer
Active, not recruitingObservational study
Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments
Stage IV Non-small Cell Lung Cancer, Stage IV Malignant Melanoma
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.
Jean Mosser, PUPH principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage IIIb and IV Non Small Cell Lung Cancer, run by Rennes University Hospital 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 3 inclusion and 3 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 12 Sep 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?
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?
Mutation profiling of circulating tumor DNA from plasma samples. (time frame: 1 year). 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 12 Sep 2016.