Lung CancerNCT00611598
DNA Repair and Genetic Susceptibility to Lung Cancer
An observational study of Lung Cancer and Single Primary Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to help us better understand the cellular changes that may lead to the development of lung cancer. We want to compare people with a second primary lung cancer with those who have only a first primary lung cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer, Single Primary Lung Cancer, Second Primary Lung Cancer
- What is being tested?
- Blood draw and Questionnaires
- How many people
- 218 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2003to 24 Mar 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: MSKCC Clinic
Who may be able to join
- Cases will be eligible for inclusion if:
- They have been diagnosed with a second primary lung cancer, and
- They speak English or a language for which we have a translated consent form, and
- They understand and agree to sign informed consent, and
- They agree to give us a blood sample, and
- They agree to give us a tissue sample when part of normal clinical procedures, and
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- They agree to complete the study questionnaires, and
- They agree to have their pathology information reviewed. This could include biopsy specimens.
- Controls will be eligible for inclusion if
- They have been diagnosed with a first primary lung cancer, and
- They speak English or a language for which we have a translated consent form, and
- They understand and agree to sign informed consent, and
- They agree to give us a blood sample, and
- They agree to give us a tissue sample when part of normal clinical procedures, and
- They agree to complete the study questionnaires,
- They agree to have their pathology information reviewed. This will could include biopsy specimens.
Who cannot join
- Subjects who do not meet the inclusion criteria as either cases or controls will not be eligible for this study.
- Control subjects who have a history of another cancer, other than nonmelanoma skin cancer or a first primary lung cancer, will not be eligible for this study.
- Control subjects who otherwise meet the eligibility requirements above but who have had chemotherapy and/or are currently being treated with chemotherapy will be excluded from the functional assay, but not from the genotyping.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to help us better understand the cellular changes that may lead to the development of lung cancer. We want to compare people with a second primary lung cancer with those who have only a first primary lung cancer. We hope to use the information obtained in this study as the basis for future studies and will not regard the results from this study as final.
We will analyze your blood cells and DNA to measure the changes in several genes that we believe may be involved in lung cancer. We also want to evaluate the capacity for your DNA to repair itself.
- Being tested
- Blood draw and Questionnaires
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw and QuestionnairesOther
Pt will have three green top tubes of blood drawn. The questionnaire will be filled out by the study subject. This may be completed at home and mailed in a provided stamped addressed envelope if the patient prefer, or obtained by phone interview with a research assistant.
Blood draw and QuestionnairesOther
Pt will have three green top tubes of blood drawn. The questionnaire will be filled out by the study subject. This may be completed at home and mailed in a provided stamped addressed envelope if the patient prefer, or obtained by phone interview with a research assistant.
| Study group | Role | What they receive |
|---|---|---|
| 1 | second primary lung cancer Receives: Other: Blood draw and Questionnaires | |
| 2 | single primary lung cancer Receives: Other: Blood draw and Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
To conduct a pilot study of the role of DNA repair in lung cancer subjects with high genetic risk - those with a second primary lung cancer - compared to subjects with only one lung cancer.
Measured: conclusion of the study
Secondary outcomes (1)
To determine the association between cellular DNA repair and genetic alterations in DNA repair and associated pathways.
Measured: conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study start11 Feb 2003
- Primary completion24 Mar 2023
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene Orlow, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611598
- Sponsor's protocol ID
- 03-003
- Status last verified
- Mar 2023
- First submitted
- 28 Jan 2008
- Last updated
- 29 Mar 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DNA Repair and Genetic Susceptibility to Lung Cancer
- ClinicalTrials.gov ID
- NCT00611598
- Acronym / sponsor ID
- 03-003
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 11 Feb 2003 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 11 Feb 2008 (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 help us better understand the cellular changes that may lead to the development of lung cancer. We want to compare people with a second primary lung cancer with those who have only a first primary lung cancer. We hope to use the information obtained in this study as the basis for future studies and will not regard the results from this study as final.
We will analyze your blood cells and DNA to measure the changes in several genes that we believe may be involved in lung cancer. We also want to evaluate the capacity for your DNA to repair itself.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Blood draw and Questionnairessecond primary lung cancer |
| 2 | – | Other: Blood draw and Questionnairessingle primary lung cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- MSKCC Clinic
Key inclusion criteria (16 listed)
- Cases will be eligible for inclusion if:
- They have been diagnosed with a second primary lung cancer, and
- They speak English or a language for which we have a translated consent form, and
- They understand and agree to sign informed consent, and
- They agree to give us a blood sample, and
Key exclusion criteria (3 listed)
- Subjects who do not meet the inclusion criteria as either cases or controls will not be eligible for this study.
- Control subjects who have a history of another cancer, other than nonmelanoma skin cancer or a first primary lung cancer, will not be eligible for this study.
- Control subjects who otherwise meet the eligibility requirements above but who have had chemotherapy and/or are currently being treated with chemotherapy will be excluded from the functional assay, but not from the genotyping.
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 draw and QuestionnairesPt will have three green top tubes of blood drawn. The questionnaire will be filled out by the study subject. This may be completed at home and mailed in a provided stamped addressed envelope if the patient prefer, or obtained by phone interview with a research assistant. | Other | 1 |
| Blood draw and QuestionnairesPt will have three green top tubes of blood drawn. The questionnaire will be filled out by the study subject. This may be completed at home and mailed in a provided stamped addressed envelope if the patient prefer, or obtained by phone interview with a research assistant. | Other | 2 |
Primary outcome
To conduct a pilot study of the role of DNA repair in lung cancer subjects with high genetic risk - those with a second primary lung cancer - compared to subjects with only one lung cancer.
Time frame: conclusion of the study
1 secondary outcome
To determine the association between cellular DNA repair and genetic alterations in DNA repair and associated pathways.
Time frame: conclusion of the study
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 29 Mar 2023.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Irene Orlow, PhD principal investigator
Memorial Sloan Kettering Cancer Center
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 Single Primary Lung Cancer, run by Memorial Sloan Kettering Cancer Center 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 16 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 29 Mar 2023. 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?
To conduct a pilot study of the role of DNA repair in lung cancer subjects with high genetic risk - those with a second primary lung cancer - compared to subjects with only one lung cancer. (time frame: conclusion of the study). 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 29 Mar 2023.