Carcinoma, Non-Small-Cell LungNCT00973427
DNA Chip Based Prognosis of Lung Cancer
An observational study of Carcinoma, Non-Small-Cell Lung, run by Medical Prognosis Institute A/S at 5 sites in 2 countries.
Trial summary
The purpose of the study is to determine whether a DNA chip, designed by Medical Prognosis Institute (MPI), can provide an accurate prognosis for survival of NSCLC (adeno-, squamous and large cell lung cancer). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- How many people
- 144 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jun 2008to Sep 2014
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population consist of subjects being examined for NSCLC at Roswell Park Cancer Institute (US), University of Alabama (US), Copenhagen University (DK), Odense University Hospital (DK) and Aarhus University Hospital (DK)
Who may be able to join
- A histological diagnosis of primary NSCLC stage Ia
- Surgical removal of the tumor
- Age between 18 and 75 years
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- A primary NSCLC stage Ia diagnosis that is changed to not primary NSCLC or NSCLC stage Ib-IV after surgery.
- Adjuvant treatment with chemotherapy.
- Prior history of cancer in the past 5 years or breast cancer at any time.
- Life expectancy less than 3 years in the opinion of the investigator due to concurrent illnesses.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Denmark3 sites
Aarhus University Hospital
Aarhus, 8200
University of Copenhagen
Copenhagen, 2100
Odense University Hospital
Odense, 5000
United States2 sites
University of Alabama
Birmingham, Alabama, 35294
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
The purpose of the study is to determine whether a DNA chip, designed by Medical Prognosis Institute (MPI), can provide an accurate prognosis for survival of NSCLC (adeno-, squamous and large cell lung cancer).
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- NSCLC
- 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.
Disease-related survival
Measured: 5 years
Secondary outcomes (1)
Time to progression
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startJun 2008
- Primary completionSep 2014
- Study completionSep 2014
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Prognosis Institute A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steen Knudsen, PhD, Study chair, Medical Prognosis Institute (MPI)Jens B. Sørensen, MD, Study director, Dept. Oncology, Copenhagen UniversityJesper Ravn, MD, Study director, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973427
- Sponsor's protocol ID
- MPI-1001
- Other IDs
- H-B-2007-099, WIRB Protocol #20080904
- Status last verified
- Sep 2015
- First submitted
- 8 Sep 2009
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Chip Based Prognosis of Lung Cancer
- ClinicalTrials.gov ID
- NCT00973427
- Acronym / sponsor ID
- MPI-1001
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- NSCLC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Medical Prognosis Institute A/SIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Sep 2009 (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 the study is to determine whether a DNA chip, designed by Medical Prognosis Institute (MPI), can provide an accurate prognosis for survival of NSCLC (adeno-, squamous and large cell lung cancer).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population consist of subjects being examined for NSCLC at Roswell Park Cancer Institute (US), University of Alabama (US), Copenhagen University (DK), Odense University Hospital (DK) and Aarhus University Hospital (DK)
Key inclusion criteria (4 listed)
- A histological diagnosis of primary NSCLC stage Ia
- Surgical removal of the tumor
- Age between 18 and 75 years
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (4 listed)
- A primary NSCLC stage Ia diagnosis that is changed to not primary NSCLC or NSCLC stage Ib-IV after surgery.
- Adjuvant treatment with chemotherapy.
- Prior history of cancer in the past 5 years or breast cancer at any time.
- Life expectancy less than 3 years in the opinion of the investigator due to concurrent illnesses.
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
Disease-related survival
Time frame: 5 years
1 secondary outcome
Time to progression
Time frame: 5 years
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 23 Sep 2015.
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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.
Steen Knudsen, PhD study chair
Medical Prognosis Institute (MPI)
Jens B. Sørensen, MD study director
Dept. Oncology, Copenhagen University
Jesper Ravn, MD study director
University of Copenhagen
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by Medical Prognosis Institute A/S at 5 sites in 2 countries.
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 4 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 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark, United States. 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?
Disease-related survival (time frame: 5 years). 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 23 Sep 2015.