Primary Lung CancerLDxNCT01830426
Circulating Tumor Cells in Non-Small Cell Lung Carcinoma
An observational study of Primary Lung Cancer, run by Epic Sciences at 3 sites in United States.
Trial summary
The purpose of this study is to establish the circulating tumor cell (CTC) assay as a surrogate for tissue diagnosis of suspected primary lung cancer. This is done through evaluating clinical and molecular markers to stratify the outcome/survival in patients with thoracic malignancies treated at Yale… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Lung Cancer
- How many people
- 232 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2012to Jan 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A primary lung cancer bearing population will be studied. Eligible patients will include those presenting to the specified clinical centers with a tissue confirmed primary lung cancer or radiographic abnormality deemed highly suspicious for primary lung cancer by collaborating clinical team, in whom definitive tissue diagnosis is planned. All stages of primary lung cancer will considered.
Who may be able to join
- Suspected lung cancer
- Planned to undergo tissue biopsy. Tissue biopsy does not need to be limited to an intrathoracic structures. Biopsies of the supraclavicular lymph nodes are allowed
- Age >18
Who cannot join
- Patients with history of a separate (not a primary lung cancer) malignancy within past two years.
- Recent history (past two weeks) of trauma (INCLUDING diagnostic surgery, biopsy, etc)
- Prior lung cancer treatment chemotherapy, radiation, surgery, etc. in past two years.
- Inability to provide informed consent.
- Hgb less than 8.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Billings Clinic Cancer Center
Billings, Montana, 59101
Moores Cancer Center
La Jolla, California, 92093
Yale University
New Haven, Connecticut, 06510
About this study
Official title: Phase 2 Study of Circulating Tumor Cell in Non-Small Cell Lung Carcinoma
The purpose of this study is to establish the circulating tumor cell (CTC) assay as a surrogate for tissue diagnosis of suspected primary lung cancer. This is done through evaluating clinical and molecular markers to stratify the outcome/survival in patients with thoracic malignancies treated at Yale University/Yale-New Haven Hospital, University of California San Diego/Moores Cancer Center, Billings Clinic Cancer Center.
- Conditions
- Primary Lung Cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
CTC Enumeration
After informed consent of the patients, a single tube of blood will be drawn and processed according to the standard protocol. These blood draws will occur upon patient screening or rather the baseline of their treatment, a 6-12 week follow-up, as well as a 12 month follow-up.Furthermore, a biopsy will be taken between baseline and 6-12 week follow-up which will be used upon results of CTC enumeration to illustrate concordance. Epic Sciences staff is fully blinded to the clinical data of the patients until final analysis. Patients will be considered CTC positive at a count of greater than 2 CTCs per ml of blood.
Measured: 3 months from baseline, an average of 2 weeks post patient tissue biopsy
Secondary outcomes (3)
Lung Cancer Subtyping
Based on the blood draws from the primary outcome, Epic will utilize the identified CTCs as biopsy material for lung cancer subtyping that distinguishes between adenocarcinoma (ACA), squamous cell carcinoma (SCC) from other types of primary lung cancer. Lung cancer histology will be evaluated for each patient sample: Two slides will be run with the ACA-CTC assay (TTF1 or Napsin A) and two slides will be run with the SCC-CTC (p63) assay. For the purpose of assay development and validation, we have all already procured a validated set of patient samples with known histology.
Measured: 3 months from baseline, an average of 2 weeks post patient tissue biopsy
Nodal Staging
For patients ultimately diagnosed with lung cancer and deemed to be surgical candidates, surgical intervention will be performed. In accordance to a standard practice mediastinal lymph node dissection will accompany the surgery. Nodal staging for each patient in the trial with diagnosed lung cancer will be evaluated clinically and pathologically. Clinical staging will be determined by the treating clinician prior to information being available from surgery and recorded in the case report form. The diagnostic accuracy of the clinical stage will be determined by comparison with the pathological stage which will be abstracted from the pathology report for surgically staged patients. We will determine the sensitivity and specificity of the CTC count as a test that identifies patients who will ultimately be "upstaged" from N0 to N1 or from N1 to N2-3 at the time of surgical staging when comparing the clinical and pathological stage.
Measured: 3 months from baseline, an average of 2 weeks post patient tissue biopsy
Establish the Prognostic Value by measuring CTC count over time.
This measure will work to establish the prognostic value of the initial test by drawing the correlation with outcome data. For the 260 patients recruited to this clinical trial, stage specific Kaplan-Meier overall and disease free survival curves for the population will be generated after 2 years of follow-up. For each stage, the results of the CTCs will then be used to separate the population for each stage into a low CTC and high CTC group to determine if the disease free survival curves for each stage separate on the basis of the assay and are statistically significant using a retrospective analysis of the prospectively collected data, this will determine if knowledge of the CTC assay provides useful information about disease free survival beyond that which is obtained by clinical staging alone.
Measured: Baseline, 3 months, 24 months and 66 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epic Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yale University, Billings Clinic, University of California, San Diego, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ryan Dittamore, MBA, Principal investigator, Epic Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830426
- Sponsor's protocol ID
- HHSN261201200049C
- Other IDs
- HHSN26120100049C
- Acronym
- LDx
- Status last verified
- Jan 2016
- First submitted
- 25 Mar 2013
- Last updated
- 22 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Circulating Tumor Cell in Non-Small Cell Lung Carcinoma
- ClinicalTrials.gov ID
- NCT01830426
- Acronym / sponsor ID
- LDx / HHSN261201200049C
- Conditions
- Primary Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Epic SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Yale University, Billings Clinic, University of California, San Diego, National Cancer Institute (NCI)
- Study start
- Nov 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 12 Apr 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 establish the circulating tumor cell (CTC) assay as a surrogate for tissue diagnosis of suspected primary lung cancer. This is done through evaluating clinical and molecular markers to stratify the outcome/survival in patients with thoracic malignancies treated at Yale University/Yale-New Haven Hospital, University of California San Diego/Moores Cancer Center, Billings Clinic Cancer Center.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A primary lung cancer bearing population will be studied. Eligible patients will include those presenting to the specified clinical centers with a tissue confirmed primary lung cancer or radiographic abnormality deemed highly suspicious for primary lung cancer by collaborating clinical team, in whom definitive tissue diagnosis is planned. All stages of primary lung cancer will considered.
Key inclusion criteria (3 listed)
- Suspected lung cancer
- Planned to undergo tissue biopsy. Tissue biopsy does not need to be limited to an intrathoracic structures. Biopsies of the supraclavicular lymph nodes are allowed
- Age >18
Key exclusion criteria (5 listed)
- Patients with history of a separate (not a primary lung cancer) malignancy within past two years.
- Recent history (past two weeks) of trauma (INCLUDING diagnostic surgery, biopsy, etc)
- Prior lung cancer treatment chemotherapy, radiation, surgery, etc. in past two years.
- Inability to provide informed consent.
- Hgb less than 8.
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
CTC Enumeration
Time frame: 3 months from baseline, an average of 2 weeks post patient tissue biopsy
After informed consent of the patients, a single tube of blood will be drawn and processed according to the standard protocol. These blood draws will occur upon patient screening or rather the baseline of their treatment, a 6-12 week follow-up, as well as a 12 month follow-up.Furthermore, a biopsy will be taken between baseline and 6-12 week follow-up which will be used upon results of CTC enumeration to illustrate concordance. Epic Sciences staff is fully blinded to the clinical data of the patients until final analysis. Patients will be considered CTC positive at a count of greater than 2 CTCs per ml of blood.
3 secondary outcomes
Lung Cancer Subtyping
Time frame: 3 months from baseline, an average of 2 weeks post patient tissue biopsy
Nodal Staging
Time frame: 3 months from baseline, an average of 2 weeks post patient tissue biopsy
Establish the Prognostic Value by measuring CTC count over time.
Time frame: Baseline, 3 months, 24 months and 66 months
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 Jan 2016.
Related trials for Primary Lung Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
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.
Ryan Dittamore, MBA principal investigator
Epic Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Lung Cancer, run by Epic Sciences at 3 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 3 inclusion and 5 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 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
CTC Enumeration (time frame: 3 months from baseline, an average of 2 weeks post patient tissue biopsy). 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 Jan 2016.