Non Small Cell Lung CancerNCT01990651
Study of Use of CTC in NSCLC
An observational study of Non Small Cell Lung Cancer and Chronic Obstructive Pulmonary Disease, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to assess whether the detection of circulating tumor cells (CTC) could be used as a tool to earlier diagnose, more accurately predict treatment response / failure and predict overall survival in non-small cell lung cancer (NSCLC) patients Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non Small Cell Lung Cancer, Chronic Obstructive Pulmonary Disease
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2014
- 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: primary care clinic
Who may be able to join
- For subjects with lung malignancies:
- 18 years of age and older
- Diagnosis of new or recurrent non-small cell lung cancer
- Awaiting treatment and follow up
- Have radiographic measurable metastatic disease that can be followed
- Be able to sign an IRB approved informed consent form
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- Life expectancy greater than 12 weeks
- For subjects with COPD and without lung malignancies:
- 18 years of age and older
- Diagnosis of COPD
- No current or prior malignancies (except squamous or basal cell carcinoma of the skin)
- Be able to sign an IRB approved informed consent form
- For Healthy Control Subjects (Dry Runs):
- 18 years of age and older
- Has no current or prior malignancies (except squamous or basal cell carcinoma of the skin)
- Patients must sign an IRB approved informed consent form
Who cannot join
- For subjects with lung malignancies:
- Have other concurrent lung cancer malignancies, or any other form of malignancy (except squamous or basal cell carcinoma of the skin)
- ECOG performance status of 4
- Pregnant female (self-reporting)
- Cognitively Impaired
- Prisoner
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- For subjects with COPD and without lung malignancies and Healthy Controls:
- Any other form of malignancy (except squamous or basal cell carcinoma of the skin)
- Pregnant female (self reporting)
- Cognitively impaired
- Prisoner
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia Health System
Charlottesville, Virginia, 22908
Royanne Dell, 434-924-9496, RLB8Y@virginia.ed
Thao Dang, MD
About this study
Official title: The Use of Circulating Tumor Cells in Non-Small Cell Lung Cancer: Novel Isolation Methods and Clinical Applications
The purpose of this study is to assess whether the detection of circulating tumor cells (CTC) could be used as a tool to earlier diagnose, more accurately predict treatment response / failure and predict overall survival in non-small cell lung cancer (NSCLC) patients
Read the detailed description
Lung cancer remains the most common cause of cancer mortality in the world for both men and women. More than half of patients diagnosed will die within the first year. Given these concerning facts, we are in need of novel methodologies to diagnose patients at earlier stages of the disease, more accurately predict treatment response / failure and predict overall survival.
The use of CTC has been investigated and shown to predict progression free survival and overall survival in metastatic breast cancer, and recommended as a breast cancer tumor marker by the American Society of Clinical Oncology. There have also been relationships between CTC's and survival, shown in metastatic colorectal and prostate cancer. However, CTC's have not been thoroughly investigated in non-small cell lung cancer. This trial will assess if the detection of circulating tumor cells could be used as a tool to help further advance treatment for NSCLC patients.
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the correlation between the number of circulating tumor cells (CTC) and clinical stage of the disease
Measured: Completed within 6 months of the last sample collected
In Stage I, II or III patients with resectable disease, to obtain preliminary data to assess whether the number of CTC in post operative peripheral blood samples decrease compared with the number of CTC in the pre operative peripheral blood samples
Measured: Measured up to 12 week post op
To obtain preliminary data to assess whether lower numbers of CTC are associated with a reduction in tumor burden (by RECIST criteria) on imaging
Measured: Completed within 6 months of the last sample collected
To obtain preliminary data to assess whether there is a decrease in the number of CTC during treatment with chemotherapy in Stage IV disease
Measured: measured up to completion of 4 cycles of chemo or up to 12 weeks after completion of radiation and chemo treatment
Secondary outcomes (2)
To obtain preliminary data on the association of baseline number of CTC and disease-free survival for patients with all stages of disease
Measured: Will be assessed for up to 2 years after subjects last visit
To obtain preliminary data on the association of baseline number of CTC and overall survival for patients with all stages of disease
Measured: Will be assessed for up to 2 years after subjects last visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startSep 2011
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thao Dang, MD, Principal investigator, University of Virginia Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990651
- Sponsor's protocol ID
- 15847
- Status last verified
- Nov 2013
- First submitted
- 15 Nov 2013
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Circulating Tumor Cells in Non-Small Cell Lung Cancer: Novel Isolation Methods and Clinical Applications
- ClinicalTrials.gov ID
- NCT01990651
- Acronym / sponsor ID
- 15847
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2014 (estimated)
- First posted
- 21 Nov 2013 (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 assess whether the detection of circulating tumor cells (CTC) could be used as a tool to earlier diagnose, more accurately predict treatment response / failure and predict overall survival in non-small cell lung cancer (NSCLC) patients
Detailed description
Lung cancer remains the most common cause of cancer mortality in the world for both men and women. More than half of patients diagnosed will die within the first year. Given these concerning facts, we are in need of novel methodologies to diagnose patients at earlier stages of the disease, more accurately predict treatment response / failure and predict overall survival.
The use of CTC has been investigated and shown to predict progression free survival and overall survival in metastatic breast cancer, and recommended as a breast cancer tumor marker by the American Society of Clinical Oncology. There have also been relationships between CTC's and survival, shown in metastatic colorectal and prostate cancer. However, CTC's have not been thoroughly investigated in non-small cell lung cancer. This trial will assess if the detection of circulating tumor cells could be used as a tool to help further advance treatment for NSCLC patients.
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
- primary care clinic
Key inclusion criteria (16 listed)
- 18 years of age and older
- Diagnosis of new or recurrent non-small cell lung cancer
- Awaiting treatment and follow up
- Have radiographic measurable metastatic disease that can be followed
- Be able to sign an IRB approved informed consent form
Key exclusion criteria (11 listed)
- Have other concurrent lung cancer malignancies, or any other form of malignancy (except squamous or basal cell carcinoma of the skin)
- ECOG performance status of 4
- Pregnant female (self-reporting)
- Cognitively Impaired
- Prisoner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To estimate the correlation between the number of circulating tumor cells (CTC) and clinical stage of the disease
Time frame: Completed within 6 months of the last sample collected
In Stage I, II or III patients with resectable disease, to obtain preliminary data to assess whether the number of CTC in post operative peripheral blood samples decrease compared with the number of CTC in the pre operative peripheral blood samples
Time frame: Measured up to 12 week post op
To obtain preliminary data to assess whether lower numbers of CTC are associated with a reduction in tumor burden (by RECIST criteria) on imaging
Time frame: Completed within 6 months of the last sample collected
To obtain preliminary data to assess whether there is a decrease in the number of CTC during treatment with chemotherapy in Stage IV disease
Time frame: measured up to completion of 4 cycles of chemo or up to 12 weeks after completion of radiation and chemo treatment
2 secondary outcomes
To obtain preliminary data on the association of baseline number of CTC and disease-free survival for patients with all stages of disease
Time frame: Will be assessed for up to 2 years after subjects last visit
To obtain preliminary data on the association of baseline number of CTC and overall survival for patients with all stages of disease
Time frame: Will be assessed for up to 2 years after subjects last visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2013.
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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.
Thao Dang, MD principal investigator
University of Virginia Health System
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 Non Small Cell Lung Cancer and Chronic Obstructive Pulmonary Disease, run by University of Virginia 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 11 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: status not confirmed, as of the sponsor's last update on 21 Nov 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Royanne Dell (434-924-9496, RLB8Y@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the correlation between the number of circulating tumor cells (CTC) and clinical stage of the disease (time frame: Completed within 6 months of the last sample collected). The study lists 4 primary outcomes in all. 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 21 Nov 2013.