Lung CancerNCT00504374
Gene Polymorphisms and Symptoms in Lung Cancer Patients
An observational study of Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: Construct a prospective cohort of patients diagnosed with lung cancer and dispositioned for treatment and collect information on symptoms and symptom treatments at baseline and on follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 235 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2006to 27 Apr 2017
- 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: Patients with lung cancer.
Who may be able to join
- Patient has lung cancer and is being treated at M. D. Anderson.
- At least 18 years of age
- Currently living in the United States
- Enrolled in CPN 91-001 (Molecular epidemiology of lung cancer)
- English or Spanish speaking
Who cannot join
- Patient is unable to understand the intent of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Primary Objectives:
- Construct a prospective cohort of patients diagnosed with lung cancer and dispositioned for treatment and collect information on symptoms and symptom treatments at baseline and on follow-up.
- Develop preliminary statistical models incorporating genetic data (which will be obtained from an existing protocol, CPN 91-001, Margaret Spitz), disease-related variables (e.g., stage of disease, location of tumor), clinical health status (e.g., performance status, comorbid conditions), and sociodemographic characteristics (e.g., age, sex, race) for predicting the risk of severe and persistent symptoms.
Read more
Analytical aim: To determine if symptoms (e.g., fatigue, depression, lack of appetite) will differ in severity by IL-6 gene polymorphisms (-174G/C, -597G/A, -572G/C, -373An/Tn).
This study (NIH-CA109043, Reyes-Gibby, 2004-2009) builds upon an NIH-funded (NIH-CA55769, Spitz, 2003-2008) study of the molecular epidemiology of lung cancer.
Read the detailed description
If you agree to take part in this study, upon being admitted for treatment, you will be asked about your symptoms (how severe they are and to what degree they affect your day-to-day functioning).
You will be asked to fill out a symptoms questionnaire each time you are at the clinic for your treatment and for your follow-up visits. The questionnaire will take about 5 to 10 minutes to complete each time.
You may also be contacted at home so that researchers can follow-up on your experience with symptoms (only if you are not able to come to the clinic for your chemoradiation treatment or follow-up visits). If you are contacted by phone, the call should last about 5 to 10 minutes each time.
Researchers will also try to collect some of your leftover blood (that was already drawn and stored for research studies) from a previous lung cancer study (Ecogenetics of Lung Cancer) that you participated in at M. D. Anderson. Researchers will use your leftover blood sample to look at certain genes in your blood that may affect your symptoms. If you did not have blood collected in the previous lung cancer study, you will have a blood sample (one tablespoon) drawn when you first agree to participate in this study.
This is an investigational study. Up to 320 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Lung Cancer
- Being tested
- Questionnaire
- Keywords
- Lung Cancer, Epidemiology, Symptoms, Gene Polymorphisms, Questionnaire, Survey
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Also called Survey
Symptoms questionnaire lasting about 5 to 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Symptoms Questionnaire | Patients with lung cancer. Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Symptom Severity (MD Anderson Symptom Inventory Questionnaire)
Measured: Baseline (before), during (every week for 6 weeks), and after chemoradiation therapy (at 6-12 week intervals)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2007 (estimated)
- Study start13 Jun 2006
- Primary completion27 Apr 2017
- Study completion27 Apr 2017
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 M.D. Anderson 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Cielito C. Reyes-Gibby, DrPH, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504374
- Sponsor's protocol ID
- 2006-0273
- Other IDs
- CA109043
- Status last verified
- May 2019
- First submitted
- 19 Jul 2007
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Polymorphisms and Symptoms in Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT00504374
- Acronym / sponsor ID
- 2006-0273
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Epidemiology, Symptoms, Gene Polymorphisms, Questionnaire, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Jun 2006 (actual)
- Primary completion
- 27 Apr 2017 (actual)
- Study completion
- 27 Apr 2017 (actual)
- First posted
- 20 Jul 2007 (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.
Primary Objectives:
- Construct a prospective cohort of patients diagnosed with lung cancer and dispositioned for treatment and collect information on symptoms and symptom treatments at baseline and on follow-up.
- Develop preliminary statistical models incorporating genetic data (which will be obtained from an existing protocol, CPN 91-001, Margaret Spitz), disease-related variables (e.g., stage of disease, location of tumor), clinical health status (e.g., performance status, comorbid conditions), and sociodemographic characteristics (e.g., age, sex, race) for predicting the risk of severe and persistent symptoms.
Analytical aim: To determine if symptoms (e.g., fatigue, depression, lack of appetite) will differ in severity by IL-6 gene polymorphisms (-174G/C, -597G/A, -572G/C, -373An/Tn).
This study (NIH-CA109043, Reyes-Gibby, 2004-2009) builds upon an NIH-funded (NIH-CA55769, Spitz, 2003-2008) study of the molecular epidemiology of lung cancer.
Detailed description
If you agree to take part in this study, upon being admitted for treatment, you will be asked about your symptoms (how severe they are and to what degree they affect your day-to-day functioning).
You will be asked to fill out a symptoms questionnaire each time you are at the clinic for your treatment and for your follow-up visits. The questionnaire will take about 5 to 10 minutes to complete each time.
You may also be contacted at home so that researchers can follow-up on your experience with symptoms (only if you are not able to come to the clinic for your chemoradiation treatment or follow-up visits). If you are contacted by phone, the call should last about 5 to 10 minutes each time.
Researchers will also try to collect some of your leftover blood (that was already drawn and stored for research studies) from a previous lung cancer study (Ecogenetics of Lung Cancer) that you participated in at M. D. Anderson. Researchers will use your leftover blood sample to look at certain genes in your blood that may affect your symptoms. If you did not have blood collected in the previous lung cancer study, you will have a blood sample (one tablespoon) drawn when you first agree to participate in this study.
This is an investigational study. Up to 320 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptoms Questionnaire | – | Behavioral: QuestionnairePatients with lung cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lung cancer.
Key inclusion criteria (5 listed)
- Patient has lung cancer and is being treated at M. D. Anderson.
- At least 18 years of age
- Currently living in the United States
- Enrolled in CPN 91-001 (Molecular epidemiology of lung cancer)
- English or Spanish speaking
Key exclusion criteria (1 listed)
- Patient is unable to understand the intent of the study.
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 |
|---|---|---|
| QuestionnaireAlso: SurveySymptoms questionnaire lasting about 5 to 10 minutes. | Behavioural | Symptoms Questionnaire |
Primary outcome
Patient Symptom Severity (MD Anderson Symptom Inventory Questionnaire)
Time frame: Baseline (before), during (every week for 6 weeks), and after chemoradiation therapy (at 6-12 week intervals)
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 Jun 2019.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Cielito C. Reyes-Gibby, DrPH principal investigator
M.D. Anderson 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, run by M.D. Anderson 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 5 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 4 Jun 2019. 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?
Patient Symptom Severity (MD Anderson Symptom Inventory Questionnaire) (time frame: Baseline (before), during (every week for 6 weeks), and after chemoradiation therapy (at 6-12 week intervals)). 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 4 Jun 2019.