Lung CancerNCT00568282
Identification of Circulating Tumor Cells in the Peripheral Blood of Lung Cancer Patients
An observational study of Lung Cancer, run by Stanford University at 1 site in United States.
Trial summary
The primary aim of this study is to determine whether we can identify human lung cancer tumor cells in the peripheral blood of lung cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- phlebotomy
- Type of treatment
- Surgery or procedure
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to 13 Jul 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with advanced stage NSCLC who are either newly diagnosed, or who have evidence of disease progression.
Who may be able to join
- no known prior or active malignancy
- ability to sign informed consent
- at least 18 years of age Exclusion Criteria:1. history of any other cancer other than non-melanoma skin cancer within the last 5 years Exclusion Criteria:1. history of any other cancer other than non-melanoma skin cancer within the last 5 years
- 2. pregnant women
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Identification of Circulating Tumor Cells in the Peripheral Blood of Lung Cancer Patients (Old Title: Significance of CD44 and or Epithelial Specific Antigen Positive Cells in the Peripheral Blood of Lung Cancer Patients) (LUN0017)
The primary aim of this study is to determine whether we can identify human lung cancer tumor cells in the peripheral blood of lung cancer patients.
Read the detailed description
The purpose of this study is to determine whether we can identify lung cancer cells circulating in the peripheral blood of lung cancer patients using cell surface markers found on cancer cells such as CD44 and epithelial specific antigen.
- Conditions
- Lung Cancer
- Being tested
- phlebotomy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phlebotomyProcedure or surgery
Also called blood draw
Standard of care
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine whether we can identify human lung cancer tumor cells in the peripheral blood of lung cancer patients using cell surface markers found on cancer cells.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study startFeb 2007
- Primary completion8 Mar 2017
- Study completion13 Jul 2021
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 Stanford UniversityThe 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
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather A. Wakelee, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568282
- Sponsor's protocol ID
- IRB-4086
- Other IDs
- 96710, LUN0017, 4086
- Status last verified
- Jun 2022
- First submitted
- 4 Dec 2007
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Circulating Tumor Cells in the Peripheral Blood of Lung Cancer Patients (Old Title: Significance of CD44 and or Epithelial Specific Antigen Positive Cells in the Peripheral Blood of Lung Cancer Patients) (LUN0017)
- ClinicalTrials.gov ID
- NCT00568282
- Acronym / sponsor ID
- IRB-4086
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Feb 2007 (actual)
- Primary completion
- 8 Mar 2017 (actual)
- Study completion
- 13 Jul 2021 (actual)
- First posted
- 6 Dec 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.
The primary aim of this study is to determine whether we can identify human lung cancer tumor cells in the peripheral blood of lung cancer patients.
Detailed description
The purpose of this study is to determine whether we can identify lung cancer cells circulating in the peripheral blood of lung cancer patients using cell surface markers found on cancer cells such as CD44 and epithelial specific antigen.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced stage NSCLC who are either newly diagnosed, or who have evidence of disease progression.
Key inclusion criteria (4 listed)
- no known prior or active malignancy
- ability to sign informed consent
- at least 18 years of age Exclusion Criteria:1. history of any other cancer other than non-melanoma skin cancer within the last 5 years Exclusion Criteria:1. history of any other cancer other than non-melanoma skin cancer within the last 5 years
- 2. pregnant women
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 |
|---|---|---|
| phlebotomyAlso: blood drawStandard of care | Procedure or surgery | – |
Primary outcome
to determine whether we can identify human lung cancer tumor cells in the peripheral blood of lung cancer patients using cell surface markers found on cancer cells.
Time frame: 2 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 22 Jun 2022.
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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.
Heather A. Wakelee principal investigator
Stanford University
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 Stanford University 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 22 Jun 2022. 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 determine whether we can identify human lung cancer tumor cells in the peripheral blood of lung cancer patients using cell surface markers found on cancer cells. (time frame: 2 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 22 Jun 2022.