Lung CancerNCT01570855
Chemotherapy Resistance and Sensitivity Testing in Lung Tumors
An observational study of Lung Cancer, run by Marshall University at 1 site in United States.
Trial summary
The purpose of this study is to screen chemotherapy drugs currently used to treat lung cancer and determine the most effective treatment based on results of chemo sensitivity testing on the patients own cancer cells in the laboratory. The results of this screening will not influence the patients treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Dec 2015
- 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 who have a suspected or confirmed diagnosis of lung cancer, and who are scheduled to have a diagnostic fine needle aspiration, core needle biopsy, or excisional biopsy of the lung lesion.
Who may be able to join
- suspected or confirmed diagnosis of lung cancer
- undergoing a fine needle aspiration, core biopsy, or excisional biopsy for diagnosis.
- Chemotherapy must be clinically indicated for treatment of the patient's qualifying disease
- Patient must be at least 18 years of age
- Patient must have signed an IRB approved informed consent form for the data collection study prior to entry of data into the enrollment form in the database.
Who cannot join
- Patient pathology shows benign pathology for sample submitted
- Patient is not indicated to receive chemotherapy for their disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Cabell Huntington Hospital
Huntington, West Virginia, 25701
About this study
The purpose of this study is to screen chemotherapy drugs currently used to treat lung cancer and determine the most effective treatment based on results of chemo sensitivity testing on the patients own cancer cells in the laboratory. The results of this screening will not influence the patients treatment.
Read the detailed description
The chemosensitivity assay will be performed on tissue obtained during the diagnostic fine needle aspiration, core biopsy, or excisional biopsy of the lung lesion. Cancer cells (Bulk of tumor) and Cancer Stem Cells (CSCs) will be isolated and expanded in the laboratory.
The drug screening assay will be used to evaluate the response of the CSCs and of the cancer cells to the various chemotherapy regimens.
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, chemosensitivity
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor size
Tumor response will be evaluated (progression/regression) by CT scan at 3 months from therapy start.
Clinical response to chemotherapy of lung cancer tumor cells versus lung cancer stem cells to standard of care chemo drugs will be evaluated and correlated to predicted drug by ex vivo assay.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startOct 2011
- Primary completionMay 2014
- Study completionDec 2015
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.
- 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marshall University
- Sponsor type
- University, hospital or other
- Collaborators
- Cabell Huntington Hospital
- Responsible party
- Principal investigator, Pier Paolo Claudio, M.D., Ph.D., Marshall University
- Investigators
- Pier P. Claudio, M.D., Ph. D, Principal investigator, Marshall University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570855
- Sponsor's protocol ID
- 246601-1
- Status last verified
- Apr 2016
- First submitted
- 19 Mar 2012
- Last updated
- 27 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy Resistance and Sensitivity Testing in Lung Tumors
- ClinicalTrials.gov ID
- NCT01570855
- Acronym / sponsor ID
- 246601-1
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, chemosensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Marshall UniversityUniversity, hospital or other
- Collaborators
- Cabell Huntington Hospital
- Study start
- Oct 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Apr 2012 (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 screen chemotherapy drugs currently used to treat lung cancer and determine the most effective treatment based on results of chemo sensitivity testing on the patients own cancer cells in the laboratory. The results of this screening will not influence the patients treatment.
Detailed description
The chemosensitivity assay will be performed on tissue obtained during the diagnostic fine needle aspiration, core biopsy, or excisional biopsy of the lung lesion. Cancer cells (Bulk of tumor) and Cancer Stem Cells (CSCs) will be isolated and expanded in the laboratory.
The drug screening assay will be used to evaluate the response of the CSCs and of the cancer cells to the various chemotherapy regimens.
Study design
- Observational model
- Cohort
- 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 who have a suspected or confirmed diagnosis of lung cancer, and who are scheduled to have a diagnostic fine needle aspiration, core needle biopsy, or excisional biopsy of the lung lesion.
Key inclusion criteria (5 listed)
- suspected or confirmed diagnosis of lung cancer
- Chemotherapy must be clinically indicated for treatment of the patient's qualifying disease
- Patient must be at least 18 years of age
- Patient must have signed an IRB approved informed consent form for the data collection study prior to entry of data into the enrollment form in the database.
Key exclusion criteria (2 listed)
- Patient pathology shows benign pathology for sample submitted
- Patient is not indicated to receive chemotherapy for their disease
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
Tumor size
Time frame: 3 months
Tumor response will be evaluated (progression/regression) by CT scan at 3 months from therapy start. Clinical response to chemotherapy of lung cancer tumor cells versus lung cancer stem cells to standard of care chemo drugs will be evaluated and correlated to predicted drug by ex vivo assay.
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 27 Apr 2016.
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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.
Pier P. Claudio, M.D., Ph. D principal investigator
Marshall University School of Medicine
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 Marshall 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 5 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 27 Apr 2016. 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?
Tumor size (time frame: 3 months). 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 27 Apr 2016.