Carcinoma, Non-Small-Cell LungNCT02714335
The Correlation Between MAGE-A3, PRAME Polymorphism and Expression Levels of MAGE-A3 and PRAME in NSCLC Patients
An observational study of Carcinoma, Non-Small-Cell Lung, run by Szu-Hua Pan.
Trial summary
Considering the low expression rate of Melanoma-associated antigen 3 (MAGE-A3) in Asian especially Southeast Asian, it would be great interests to investigate the potential polymorphism of MAGE-A3 in Non-Small-Cell Lung Cancer (NSCLC) patients in Taiwan. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Nov 2013
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Site will retrieve tissue samples of around 200 cases of NSCLC patients with informed consent including about 100 cases of adenocarcinoma (AC) and 100 cases of squamous cell carcinoma (SCC), with stages of IB, IIA, IIB and IIIA.
Who may be able to join
- Tissues samples up to 200 cases of NSCLS patients with informed consent, consisting of about 100 cases of adenocarcinoma (AC) and 100 cases of squamous cell carcinoma (SCC), with stage of IB, IIA, IIB and IIIA
Who cannot join
- No
About this study
Official title: An Observational Study to Determine the Correlation Between MAGE-A3, PRAME Polymorphism and Expression Levels of MAGE-A3 and PRAME in NSCLC Patients in Taiwan
Considering the low expression rate of Melanoma-associated antigen 3 (MAGE-A3) in Asian especially Southeast Asian, it would be great interests to investigate the potential polymorphism of MAGE-A3 in Non-Small-Cell Lung Cancer (NSCLC) patients in Taiwan. Meanwhile, it is also interesting to study the expression of Preferentially Expressed Antigen In Melanoma(PRAME) and Epidermal growth factor receptor (EGFR) mutation status as well as to find out significant factors which may affect their expression such as smoking status, histological types, tumour size and stages in Taiwan.
Read the detailed description
Considering the low expression rate of MAGE-A3 in Asian especially Southeast Asian, it would be great interests to investigate the potential polymorphism of MAGE-A3 in NSCLC patients in Taiwan. Meanwhile, it is also interesting to study the expression of PRAME and EGFR mutation status as well as to find out significant factors which may affect their expression such as smoking status, histological types, tumour size and stages in Taiwan
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with at least one MAGE-A3 gene single nucleotide polymorphism (SNP)
Measured: up to 44 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startDec 2010
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Szu-Hua Pan
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor-investigator, Szu-Hua Pan, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714335
- Sponsor's protocol ID
- 114764
- Status last verified
- Mar 2016
- First submitted
- 2 Mar 2016
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: • Type of publication e.g. poster, abstract, oral presentation etc. Poster and original article
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Determine the Correlation Between MAGE-A3, PRAME Polymorphism and Expression Levels of MAGE-A3 and PRAME in NSCLC Patients in Taiwan
- ClinicalTrials.gov ID
- NCT02714335
- Acronym / sponsor ID
- 114764
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Szu-Hua PanUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Dec 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 21 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.
Considering the low expression rate of Melanoma-associated antigen 3 (MAGE-A3) in Asian especially Southeast Asian, it would be great interests to investigate the potential polymorphism of MAGE-A3 in Non-Small-Cell Lung Cancer (NSCLC) patients in Taiwan. Meanwhile, it is also interesting to study the expression of Preferentially Expressed Antigen In Melanoma(PRAME) and Epidermal growth factor receptor (EGFR) mutation status as well as to find out significant factors which may affect their expression such as smoking status, histological types, tumour size and stages in Taiwan.
Detailed description
Considering the low expression rate of MAGE-A3 in Asian especially Southeast Asian, it would be great interests to investigate the potential polymorphism of MAGE-A3 in NSCLC patients in Taiwan. Meanwhile, it is also interesting to study the expression of PRAME and EGFR mutation status as well as to find out significant factors which may affect their expression such as smoking status, histological types, tumour size and stages in Taiwan
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Site will retrieve tissue samples of around 200 cases of NSCLC patients with informed consent including about 100 cases of adenocarcinoma (AC) and 100 cases of squamous cell carcinoma (SCC), with stages of IB, IIA, IIB and IIIA.
Key inclusion criteria (1 listed)
- Tissues samples up to 200 cases of NSCLS patients with informed consent, consisting of about 100 cases of adenocarcinoma (AC) and 100 cases of squamous cell carcinoma (SCC), with stage of IB, IIA, IIB and IIIA
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with at least one MAGE-A3 gene single nucleotide polymorphism (SNP)
Time frame: up to 44 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 22 Mar 2016.
- Individual participant dataSharing planned: Yes. • Type of publication e.g. poster, abstract, oral presentation etc. Poster and original article
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by Szu-Hua Pan.
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 1 inclusion and 1 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 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of patients with at least one MAGE-A3 gene single nucleotide polymorphism (SNP) (time frame: up to 44 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 22 Mar 2016.