Lung CancerNCT02370303
A Study to Isolate and Test Circulating Tumor Cells Using the ClearCell® FX EP+ System
An observational study of Lung Cancer and Lung Neoplasms, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to isolate and measure circulating tumor cells in the blood stream to advance detection of cancer and treatment monitoring. In this study, the investigators will utilize the novel technology for circulating tumor cell detection in order to evaluate their presence in patients with lung… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lung Neoplasms, Cancer of Lung
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 9 Jul 2016
- 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 a stage IB or above non-small cell lung cancer or metastatic cancer undergoing lung surgery at the Mayo Clinic in Rochester, MN.
Who may be able to join
- Stage IB and above non-small cell lung cancer or metastatic lung cancer
- Age >18 years old
- Willing and able to consent to study
- No prior history of neoadjuvant therapy.
Who cannot join
- Age <18 years old
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Pilot Study to Isolate and Test Circulating Tumor Cells Using the ClearCell® FX EP+ System
The purpose of this study is to isolate and measure circulating tumor cells in the blood stream to advance detection of cancer and treatment monitoring. In this study, the investigators will utilize the novel technology for circulating tumor cell detection in order to evaluate their presence in patients with lung cancer.
Read the detailed description
The plan is to collect both blood and tumor samples from the patient's lung cancer in order to validate this technology in detecting circulating tumor cells. The investigators will also obtain a postoperative blood sample to see if there is a decrease in the overall circulating tumor cell measurement once the tumor has been surgically removed.
- Conditions
- Lung Cancer, Lung Neoplasms, Cancer of Lung, Cancer of the Lung, Neoplasms, Lung, Neoplasms, Pulmonary
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Carcinoma, Squamous Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and types of mutations in the primary tumor.
Measured: Within 1 year
Number and type of mutations detectable in the matched circulating tumor cell samples.
Measured: Within 1 year
Secondary outcomes (1)
Concordance of mutations detected by either method.
Measured: Within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startAug 2014
- Primary completion9 Jul 2016
- Study completion9 Jul 2016
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 Mayo ClinicThe 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Clearbridge Biomedics
- Responsible party
- Principal investigator, Dennis Wigle, Mayo Clinic
- Investigators
- Dennis Wigle, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370303
- Sponsor's protocol ID
- 14-003962
- Status last verified
- Mar 2018
- First submitted
- 17 Feb 2015
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Isolate and Test Circulating Tumor Cells Using the ClearCell® FX EP+ System
- ClinicalTrials.gov ID
- NCT02370303
- Acronym / sponsor ID
- 14-003962
- Conditions
- Lung Cancer, Lung Neoplasms, Cancer of Lung, Cancer of the Lung, Neoplasms, Lung, Neoplasms, Pulmonary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Clearbridge Biomedics
- Study start
- Aug 2014
- Primary completion
- 9 Jul 2016 (actual)
- Study completion
- 9 Jul 2016 (actual)
- First posted
- 24 Feb 2015 (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 isolate and measure circulating tumor cells in the blood stream to advance detection of cancer and treatment monitoring. In this study, the investigators will utilize the novel technology for circulating tumor cell detection in order to evaluate their presence in patients with lung cancer.
Detailed description
The plan is to collect both blood and tumor samples from the patient's lung cancer in order to validate this technology in detecting circulating tumor cells. The investigators will also obtain a postoperative blood sample to see if there is a decrease in the overall circulating tumor cell measurement once the tumor has been surgically removed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a stage IB or above non-small cell lung cancer or metastatic cancer undergoing lung surgery at the Mayo Clinic in Rochester, MN.
Key inclusion criteria (4 listed)
- Stage IB and above non-small cell lung cancer or metastatic lung cancer
- Age >18 years old
- Willing and able to consent to study
- No prior history of neoadjuvant therapy.
Key exclusion criteria (2 listed)
- Age <18 years old
- Unable to provide consent
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
Number and types of mutations in the primary tumor.
Time frame: Within 1 year
Number and type of mutations detectable in the matched circulating tumor cell samples.
Time frame: Within 1 year
1 secondary outcome
Concordance of mutations detected by either method.
Time frame: Within 1 year
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 21 Mar 2018.
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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.
Dennis Wigle, MD, PhD principal investigator
Mayo Clinic
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 Lung Neoplasms, run by Mayo Clinic 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 2 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 21 Mar 2018. 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?
Number and types of mutations in the primary tumor. (time frame: Within 1 year). The study lists 2 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 Mar 2018.