Lung CancerPhase 2NCT00084409
Iloprost in Preventing Lung Cancer in Patients at High Risk for This Disease
A Phase 2 study testing iloprost in people with Lung Cancer and Precancerous Condition, run by University of Colorado, Denver at 6 sites in United States.
Trial summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Iloprost may be effective in preventing lung cancer. PURPOSE: This randomized phase II trial is studying how well iloprost works in preventing lung cancer in patients who are at high risk for this… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lung Cancer, Precancerous Condition
- What is being tested?
- iloprost
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2001to Jan 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current or former smoker with ≥ 20 pack-year history of smoking with no tobacco use within the past 6 months
- Mild atypia or worse on sputum cytology, or
- Bronchial biopsy with mild or worse dysplasia within the past 12 months
- Age 18 and over
- SWOG (Southwest Oncology Group)0-2
- Life expectancy at least 6 months
Show all 17Show fewer
- Granulocyte count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
- Transaminases ≤ 2.5 times ULN
- Bilirubin ≤ 2.0 mg/dL
- Albumin ≥ 2.5 g/dL
- Creatinine ≤ 1.5 mg/dL
- Well-controlled atrial fibrillation OR rare (< 2 minutes) premature ventricular contractions allowed
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able and willing to undergo bronchoscopy
Who cannot join
- Clinically apparent bleeding diathesis
- Ventricular tachycardia
- Multifocal premature ventricular contractions or supraventricular tachycardias with rapid ventricular response
- Pneumonia or acute bronchitis within the past 2 weeks
- Hypoxemia (< 90% saturation with supplemental oxygen)
- Pregnant or nursing
Show all 19Show fewer
- Malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- Serious medical condition that would preclude bronchoscopy or study participation
- Clinically active coronary artery disease
- Myocardial infarction within the past 6 weeks
- Chest pain
- Congestive heart failure
- Cardiac dysrhythmia that is potentially life-threatening
- Biologic therapy (Not specified)
- More than 5 years since prior chemotherapy
- More than 6 weeks since prior inhaled steroids
- More than 5 years since prior thoracic radiotherapy
- Surgery (Not specified)
- No prior prostacyclin
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, 80045
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
About this study
Official title: A Randomized Phase II Chemoprevention Study of Iloprost Versus Placebo in Patients at High Risk for Lung Cancer
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Iloprost may be effective in preventing lung cancer.
PURPOSE: This randomized phase II trial is studying how well iloprost works in preventing lung cancer in patients who are at high risk for this disease.
Read the detailed description
OBJECTIVES:
Primary
- Compare the reversal of premalignant histological changes in the bronchial epithelium of patients at high risk for lung cancer (defined by > 20 pack years of smoking and sputum atypia) treated with iloprost vs placebo.
- Determine whether this drug modulates Ki-67 proliferation index (Antigen Ki-67) in these patients.
- Determine whether this drug affects prostaglandin metabolism in these patients.
- Determine the toxicity profile of this drug in these patients.
Secondary
- Determine whether this drug modulates a panel of biomarkers, including MCM-2(Minichromosome maintenance protein: forms DNA helicase), EGFR (Epidermal growth factor receptor: cell surface receptor for the epidermal growth factor family of proteins. Mutations in EGFR expression or activity can result in cancer.) , HER2/neu (Human epidermal growth factor receptor 2 HER2 is a member of the EGFR family), RARβ (Retinoic Acic Receptor Beta is a nuclear transcription regulator and a member of the thyroid-steroid hormone receptor superfamily), p53, FHIT (Fragile histidine triad protein is an enzyme involved in purine metabolism and had been demonstrated to be a tumor suppressor), apoptotic index, and microvessel density, in these patients.
- Determine the genes whose expression is altered by this drug in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to smoking status (current vs former) and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral iloprost twice daily.
- Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 6 months in the absence of unacceptable toxicity.
Patients are followed at 1 month and then annually thereafter.
PROJECTED ACCRUAL: A total of 152 patients (76 [38 current smokers and 38 former smokers] per treatment arm) will be accrued for this study within 2 years.
- Conditions
- Lung Cancer, Precancerous Condition
- Being tested
- iloprost, placebo
- Keywords
- non-small cell lung cancer, squamous lung dysplasia
- Medical subject headings
- Lung Neoplasms, Precancerous Conditions, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iloprostDrug
Given orally
placeboOther
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity. Receives: Drug: iloprost |
| Arm II | Placebo comparator | Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Average (Follow-up - Baseline) From All Biopsies
This outcome measure is created for each subject as follows:
From all biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated.
From all biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.Histology on bronchial biopsies pre-treatment and post-treatment will be compared. All biopsies will be graded according to the WHO classification for bronchial epithelium for this outcome, and all the following outcomes.
WHO Classification Grade Normal 1.0 Reserve Cell Hyperplasia 2.0 Metaplasia 3.0 Mild Dysplasia 4.0 Moderate Dysplasia 5.0 Severe Dysplasia 6.0 Carcinoma in Situ 7.0 Carcinoma 8.0
The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject.
Measured: Nine years
Secondary outcomes (10)
Change in Dysplasia Index (Follow-up - Baseline) Using All Biopsies
This outcome measure is created for each subject as follows:
From all biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)).
From all biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated.
The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject.
Measured: 9 Years
Change in Average (Follow-up - Baseline) Using Reference Sites
This outcome measure is created for each subject as follows:
The biopsies used in this analysis are those from the following 6 anatomical sites pre-specified in the protocol to be biopsied: RUL (Right upper lobe: the superior region of the right lung), RML (Right middle lobe: an anatomic portion of the right lung), RB6 (The carina in the right lower lobe at the entrance to the superior segment), LUL (Left upper lobe: the superior portion of the lung), LUDB (Left upper division bronchus: the carina between the lingular orifice and the left upper lobe), and LB6 (The carina in the left lower lobe at the entrance to the superior segment).
From these biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated.
From these biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.
The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject.
Measured: 9 Years
Change in Maximum (Follow-up - Baseline) Using Reference Sites
This outcome measure is created for each subject as follows:
The biopsies used in this analysis are those from the following 6 anatomical sites pre-specified in the protocol to be biopsied: RUL, RML, RB6, LUL, LUDB, and LB6.
From these biopsies scored at the baseline bronchoscopy, the maximum WHO score is used.
From these biopsies scored at the follow-up bronchoscopy, the maximum WHO score is used.
The difference (follow-up maximum - baseline maximum) is used as the outcome measure for each subject.
Measured: 9 Years
Change in Dysplasia Index (Follow-up - Baseline) Using Reference Sites
This outcome measure is created for each subject as follows:
The biopsies used in this analysis are those from the following 6 anatomical sites pre-specified in the protocol to be biopsied: RUL, RML, RB6, LUL, LUDB, and LB6.
From these biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)).
From these biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated.
The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject.
Measured: 9 Years
Change in Average (Follow-up - Baseline) Using Matched Sites
This outcome measure is created for each subject as follows:
The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating "pairs" of biopsies.
From these biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated.
From these biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.
The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject.
Measured: 9 Years
Change in Maximum (Follow-up - Baseline) Using Matched Sites
This outcome measure is created for each subject as follows:
The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies.
From these biopsies scored at the baseline bronchoscopy, the maximum WHO score is used.
From these biopsies scored at the follow-up bronchoscopy, the maximum WHO score is used.
The difference (follow-up maximum - baseline maximum) is used as the outcome measure for each subject.
Measured: 9 Years
Change in Dysplasia Index (Follow-up - Baseline) Using Matched Sites
This outcome measure is created for each subject as follows:
The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies.
From these biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)).
From these biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated.
The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject.
Measured: 9 Years
Change in Average (Follow-up - Baseline) Using Baseline Non-Normal Pairs
This outcome measure is created for each subject as follows:
The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating "pairs" of biopsies. Any "pair" for which the baseline WHO score was 1 (i.e. normal tissue) was excluded from the analysis.
From these biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated.
From these biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.
The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject.
Measured: 9 Years
Change in Maximum (Follow-up - Baseline) Using Baseline Non-Normal Pairs
This outcome measure is created for each subject as follows:
The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating "pairs" of biopsies. Any "pair" for which the baseline WHO score was 1 (i.e. normal tissue) was excluded from the analysis.
From these biopsies scored at the baseline bronchoscopy, the maximum WHO score is used.
From these biopsies scored at the follow-up bronchoscopy, the maximum WHO score is used.
The difference (follow-up maximum - baseline maximum) is used as the outcome measure for each subject.
Measured: 9 Years
Change in Dysplasia Index (Follow-up - Baseline) Using Baseline Non-Normal Pairs
This outcome measure is created for each subject as follows:
The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating "pairs" of biopsies. Any "pair" for which the baseline WHO score was 1 (i.e. normal tissue) was excluded from the analysis.
From these biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)).
From these biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated.
The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject.
Measured: 9 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2004 (estimated)
- Study startNov 2001
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert Keith, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00084409
- Sponsor's protocol ID
- 01-279.cc
- Other IDs
- National Cancer Institute, 01-279
- Status last verified
- May 2020
- First submitted
- 10 Jun 2004
- Last updated
- 14 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Keith RL, Blatchford PJ, Kittelson J, Minna JD, Kelly K, Massion PP, Franklin WA, Mao J, Wilson DO, Merrick DT, Hirsch FR, Kennedy TC, Bunn PA Jr, Geraci MW, Miller YE. Oral iloprost improves endobronchial dysplasia in former smokers. Cancer Prev Res (Phila). 2011 Jun;4(6):793-802. doi: 10.1158/1940-6207.CAPR-11-0057.
PubMed 21636546
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Chemoprevention Study of Iloprost Versus Placebo in Patients at High Risk for Lung Cancer
- ClinicalTrials.gov ID
- NCT00084409
- Acronym / sponsor ID
- 01-279.cc
- Conditions
- Lung Cancer, Precancerous Condition
- Keywords
- non-small cell lung cancer, squamous lung dysplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2001
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 11 Jun 2004 (estimated)
- Results
- Posted 13 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Iloprost may be effective in preventing lung cancer.
PURPOSE: This randomized phase II trial is studying how well iloprost works in preventing lung cancer in patients who are at high risk for this disease.
Detailed description
OBJECTIVES:
Primary
- Compare the reversal of premalignant histological changes in the bronchial epithelium of patients at high risk for lung cancer (defined by > 20 pack years of smoking and sputum atypia) treated with iloprost vs placebo.
- Determine whether this drug modulates Ki-67 proliferation index (Antigen Ki-67) in these patients.
- Determine whether this drug affects prostaglandin metabolism in these patients.
- Determine the toxicity profile of this drug in these patients.
Secondary
- Determine whether this drug modulates a panel of biomarkers, including MCM-2(Minichromosome maintenance protein: forms DNA helicase), EGFR (Epidermal growth factor receptor: cell surface receptor for the epidermal growth factor family of proteins. Mutations in EGFR expression or activity can result in cancer.) , HER2/neu (Human epidermal growth factor receptor 2 HER2 is a member of the EGFR family), RARβ (Retinoic Acic Receptor Beta is a nuclear transcription regulator and a member of the thyroid-steroid hormone receptor superfamily), p53, FHIT (Fragile histidine triad protein is an enzyme involved in purine metabolism and had been demonstrated to be a tumor suppressor), apoptotic index, and microvessel density, in these patients.
- Determine the genes whose expression is altered by this drug in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to smoking status (current vs former) and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral iloprost twice daily.
- Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 6 months in the absence of unacceptable toxicity.
Patients are followed at 1 month and then annually thereafter.
PROJECTED ACCRUAL: A total of 152 patients (76 [38 current smokers and 38 former smokers] per treatment arm) will be accrued for this study within 2 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: iloprostPatients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity. |
| Arm II | Placebo comparator | Other: placeboPatients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Current or former smoker with ≥ 20 pack-year history of smoking with no tobacco use within the past 6 months
- Mild atypia or worse on sputum cytology, or
- Bronchial biopsy with mild or worse dysplasia within the past 12 months
- Age 18 and over
- SWOG (Southwest Oncology Group)0-2
Key exclusion criteria (19 listed)
- Clinically apparent bleeding diathesis
- Ventricular tachycardia
- Multifocal premature ventricular contractions or supraventricular tachycardias with rapid ventricular response
- Pneumonia or acute bronchitis within the past 2 weeks
- Hypoxemia (< 90% saturation with supplemental oxygen)
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 |
|---|---|---|
| iloprostGiven orally | Drug | Arm I |
| placeboGiven orally | Other | Arm II |
Primary outcome
Change in Average (Follow-up - Baseline) From All Biopsies
Time frame: Nine years
This outcome measure is created for each subject as follows: From all biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated. From all biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.Histology on bronchial biopsies pre-treatment and post-treatment will be compared. All biopsies will be graded according to the WHO classification for bronchial epithelium for this outcome, and all the following outcomes. WHO Classification Grade Normal 1.0 Reserve Cell Hyperplasia 2.0 Metaplasia 3.0 Mild Dysplasia 4.0 Moderate Dysplasia 5.0 Severe Dysplasia 6.0 Carcinoma in Situ 7.0 Carcinoma 8.0 The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject.
10 secondary outcomes
Change in Dysplasia Index (Follow-up - Baseline) Using All Biopsies
Time frame: 9 Years
Change in Average (Follow-up - Baseline) Using Reference Sites
Time frame: 9 Years
Change in Maximum (Follow-up - Baseline) Using Reference Sites
Time frame: 9 Years
Change in Dysplasia Index (Follow-up - Baseline) Using Reference Sites
Time frame: 9 Years
Change in Average (Follow-up - Baseline) Using Matched Sites
Time frame: 9 Years
Change in Maximum (Follow-up - Baseline) Using Matched Sites
Time frame: 9 Years
Change in Dysplasia Index (Follow-up - Baseline) Using Matched Sites
Time frame: 9 Years
Change in Average (Follow-up - Baseline) Using Baseline Non-Normal Pairs
Time frame: 9 Years
Change in Maximum (Follow-up - Baseline) Using Baseline Non-Normal Pairs
Time frame: 9 Years
Change in Dysplasia Index (Follow-up - Baseline) Using Baseline Non-Normal Pairs
Time frame: 9 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21636546Keith RL, Blatchford PJ, Kittelson J, Minna JD, Kelly K, Massion PP, Franklin WA, Mao J, Wilson DO, Merrick DT, Hirsch FR, Kennedy TC, Bunn PA Jr, Geraci MW, Miller YE. Oral iloprost improves endobronchial dysplasia in former smokers. Cancer Prev Res (Phila). 2011 Jun;4(6):793-802. doi: 10.1158/1940-6207.CAPR-11-0057.
- ClinicalTrials.GovLink 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.
Robert Keith, MD principal investigator
University of Colorado, Denver
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing iloprost in people with Lung Cancer and Precancerous Condition, run by University of Colorado, Denver at 6 sites 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 17 inclusion and 19 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 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Average (Follow-up - Baseline) From All Biopsies (time frame: Nine 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 NCT00084409, which also lists 1 linked publication.
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 14 May 2020.