Lung CancerNCT02445183
COPDGene/Lung Cancer Center Database
An observational study of Lung Cancer and COPD, run by National Jewish Health at 1 site in United States.
Trial summary
The COPDGene® / Lung Cancer Database Study is a nested case-control study. This study is an ancillary study to COPDGene® Phase 1 and Phase 2. Lung cancer cases, which have been reported by COPDGene® subjects since the time of COPDGene® study enrollment, will be retrospectively verified with additional medical data… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Lung Cancer, COPD
- What is being tested?
- None, N/A
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to 22 Sep 2020
- How long will I take part?
- 5 Years
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects eligible for study are those enrolled in the COPDGene®. Subjects will be screened for enrollment through the COPDGene® longitudinal follow-up questionnaire or during their Phase 2 visit. Those patients that answer yes to "since the last follow up have you been diagnosed with cancer?" will be contacted by a study coordinator and offered enrollment in the COPDGene®/Lung Cancer Database.
Who may be able to join
- Subjects must meet all of the following criteria
- Be enrolled in COPDGene® Phase 1 with or without enrollment in Phase 2 with newly diagnosed, (within the time of enrollment), non-small cell lung cancer (NSCLC) or small-cell lung cancer (SCLC).
- Documented GOLD stage 1-4 COPD or a history of smoking with no COPD
- Signed HIPAA Research Authorization and a Release of Protected Health Information form to collect and review medical records regarding lung cancer diagnosis, treatment, and outcome
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The COPDGene® / Lung Cancer Database Study is a nested case-control study. This study is an ancillary study to COPDGene® Phase 1 and Phase 2. Lung cancer cases, which have been reported by COPDGene® subjects since the time of COPDGene® study enrollment, will be retrospectively verified with additional medical data collection pertaining to lung cancer. Additional 'control' subjects will also be identified and verified as a 'no lung cancer controls'. Data previously collected through the COPDGene® Study, including QCT results and clinical results (medication use, rate of acute exacerbations of COPD, etc) will be used as variables for analysis.
Read the detailed description
COPDGene® subjects will be screened through several mechanisms for enrollment into the Lung Cancer Database:
- The COPDGene® Phase 1 Longitudinal Follow-up Questionnaire.
- The COPDGene® Phase 2 Medical History Questionnaire at Visit 1
- Medical Records Collection through the Mortality Adjudication Committee
Potential cases will be those who respond yes to lung cancer will be contacted by phone by a study coordinator and be screened for the COPDGene® Lung Cancer Database. Medical records will be analyzed to determine the patient's cancer diagnosis, pathology, and treatment. Information will be collected at each individual institution, de-identified, and entered into the password-protected COPDGene® DCC lung cancer database, through a web-based interface. The survival data will be obtained through review of medical records or the Social Security Death Index in conjunction with the COPDGene® mortality adjudication committee. For the nested case-control study, controls will be matched from the those subjects on COPDGene who answered 'No' to the longitudinal follow-up question "have you been diagnosed with lung cancer" as per COPDGene protocol.
Medical records regarding the patient's cancer diagnosis, pathology and treatment will be collected following signed release of medical information from the patient. The following information will be collected and entered into a database. The survival data will be obtained through review of medical records or the Social Security Death Index.
- Date of diagnosis ii. Type of specimen iii. Laterality iv. Lobe v. Record of any false positives (can be used as verified controls) b. Pathology Findings: i. Histology ii. Molecular Analysis, if done. iii. Stage (TNM classification) iv. Histologic grade c. Treatment i. Surgery ii. Radiation iii. Chemotherapy iv. Presentation at Tumor Board d. Outcomes i. Recurrence, Second primary cancers ii. Survival after cancer diagnosis, Cause of death Study coordinators at each site contact subjects who have self-reported lung cancer or were identified as having lung cancer by follow-up clinic visits and complete the lung cancer data form. The data collected on each subject is de-identified at the recruiting site prior to being downloaded into the COPDGene® DCC located at National Jewish Health. A lung cancer adjudication committee, including Drs. Carr and Bowler, will review each case for accuracy and completeness.
- Conditions
- Lung Cancer, COPD
- Being tested
- None, N/A
- Medical subject headings
- Lung Neoplasms, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None, N/AOther
| Study group | Role | What they receive |
|---|---|---|
| Lung Cancer | Confirmed diagnosis of lung cancer Receives: Other: None, N/A | |
| No Lung Cancer Controls | Unconfirmed lung cancer diagnosis, false positive Receives: Other: None, N/A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify lung cancer variables
Use existing COPDGene® quantitative HRCT and clinical data to perform a nested case-control study and perform a univariate analysis to select significant variables for the development of lung cancer.
Measured: 1.5 years
Secondary outcomes (1)
Probability of lung cancer based on variables
Construct a multivariate model from the results of the univariate analysis to calculate the odds ratios for the variables that predict lung cancer
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startDec 2013
- Primary completion22 Sep 2020
- Study completion22 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies 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-control
- Time perspective
- Other
- Enrolment
- 250 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02445183
- Sponsor's protocol ID
- HS 2815
- Status last verified
- Mar 2021
- First submitted
- 11 May 2015
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
El Kaddouri B, Strand MJ, Baraghoshi D, Humphries SM, Charbonnier JP, van Rikxoort EM, Lynch DA. Fleischner Society Visual Emphysema CT Patterns Help Predict Progression of Emphysema in Current and Former Smokers: Results from the COPDGene Study. Radiology. 2021 Feb;298(2):441-449. doi: 10.1148/radiol.2020200563. Epub 2020 Dec 15.
PubMed 33320065Bradford E, Jacobson S, Varasteh J, Comellas AP, Woodruff P, O'Neal W, DeMeo DL, Li X, Kim V, Cho M, Castaldi PJ, Hersh C, Silverman EK, Crapo JD, Kechris K, Bowler RP. The value of blood cytokines and chemokines in assessing COPD. Respir Res. 2017 Oct 24;18(1):180. doi: 10.1186/s12931-017-0662-2.
PubMed 29065892
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPDGene/Lung Cancer Center Database
- ClinicalTrials.gov ID
- NCT02445183
- Acronym / sponsor ID
- HS 2815
- Conditions
- Lung Cancer, COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- Dec 2013
- Primary completion
- 22 Sep 2020 (actual)
- Study completion
- 22 Sep 2020 (actual)
- First posted
- 15 May 2015 (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 COPDGene® / Lung Cancer Database Study is a nested case-control study. This study is an ancillary study to COPDGene® Phase 1 and Phase 2. Lung cancer cases, which have been reported by COPDGene® subjects since the time of COPDGene® study enrollment, will be retrospectively verified with additional medical data collection pertaining to lung cancer. Additional 'control' subjects will also be identified and verified as a 'no lung cancer controls'. Data previously collected through the COPDGene® Study, including QCT results and clinical results (medication use, rate of acute exacerbations of COPD, etc) will be used as variables for analysis.
Detailed description
COPDGene® subjects will be screened through several mechanisms for enrollment into the Lung Cancer Database:
- The COPDGene® Phase 1 Longitudinal Follow-up Questionnaire.
- The COPDGene® Phase 2 Medical History Questionnaire at Visit 1
- Medical Records Collection through the Mortality Adjudication Committee
Potential cases will be those who respond yes to lung cancer will be contacted by phone by a study coordinator and be screened for the COPDGene® Lung Cancer Database. Medical records will be analyzed to determine the patient's cancer diagnosis, pathology, and treatment. Information will be collected at each individual institution, de-identified, and entered into the password-protected COPDGene® DCC lung cancer database, through a web-based interface. The survival data will be obtained through review of medical records or the Social Security Death Index in conjunction with the COPDGene® mortality adjudication committee. For the nested case-control study, controls will be matched from the those subjects on COPDGene who answered 'No' to the longitudinal follow-up question "have you been diagnosed with lung cancer" as per COPDGene protocol.
Medical records regarding the patient's cancer diagnosis, pathology and treatment will be collected following signed release of medical information from the patient. The following information will be collected and entered into a database. The survival data will be obtained through review of medical records or the Social Security Death Index.
- Date of diagnosis ii. Type of specimen iii. Laterality iv. Lobe v. Record of any false positives (can be used as verified controls) b. Pathology Findings: i. Histology ii. Molecular Analysis, if done. iii. Stage (TNM classification) iv. Histologic grade c. Treatment i. Surgery ii. Radiation iii. Chemotherapy iv. Presentation at Tumor Board d. Outcomes i. Recurrence, Second primary cancers ii. Survival after cancer diagnosis, Cause of death Study coordinators at each site contact subjects who have self-reported lung cancer or were identified as having lung cancer by follow-up clinic visits and complete the lung cancer data form. The data collected on each subject is de-identified at the recruiting site prior to being downloaded into the COPDGene® DCC located at National Jewish Health. A lung cancer adjudication committee, including Drs. Carr and Bowler, will review each case for accuracy and completeness.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung Cancer | – | Other: None, N/AConfirmed diagnosis of lung cancer |
| No Lung Cancer Controls | – | Other: None, N/AUnconfirmed lung cancer diagnosis, false positive |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects eligible for study are those enrolled in the COPDGene®. Subjects will be screened for enrollment through the COPDGene® longitudinal follow-up questionnaire or during their Phase 2 visit. Those patients that answer yes to "since the last follow up have you been diagnosed with cancer?" will be contacted by a study coordinator and offered enrollment in the COPDGene®/Lung Cancer Database.
Key inclusion criteria (4 listed)
- Subjects must meet all of the following criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| None, N/A | Other | Lung Cancer, No Lung Cancer Controls |
Primary outcome
Identify lung cancer variables
Time frame: 1.5 years
Use existing COPDGene® quantitative HRCT and clinical data to perform a nested case-control study and perform a univariate analysis to select significant variables for the development of lung cancer.
1 secondary outcome
Probability of lung cancer based on variables
Time frame: 1.5 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 4 Mar 2021.
- Derived from this study: PubMed 33320065El Kaddouri B, Strand MJ, Baraghoshi D, Humphries SM, Charbonnier JP, van Rikxoort EM, Lynch DA. Fleischner Society Visual Emphysema CT Patterns Help Predict Progression of Emphysema in Current and Former Smokers: Results from the COPDGene Study. Radiology. 2021 Feb;298(2):441-449. doi: 10.1148/radiol.2020200563. Epub 2020 Dec 15.
- Derived from this study: PubMed 29065892Bradford E, Jacobson S, Varasteh J, Comellas AP, Woodruff P, O'Neal W, DeMeo DL, Li X, Kim V, Cho M, Castaldi PJ, Hersh C, Silverman EK, Crapo JD, Kechris K, Bowler RP. The value of blood cytokines and chemokines in assessing COPD. Respir Res. 2017 Oct 24;18(1):180. doi: 10.1186/s12931-017-0662-2.
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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.
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 Lung Cancer and COPD, run by National Jewish Health at 1 site in United States.
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 0 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 4 Mar 2021. 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 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?
Identify lung cancer variables (time frame: 1.5 years). 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 NCT02445183, which also lists 2 linked publications.
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 4 Mar 2021.