Non-small Cell Lung CancerNCT02135679
The Detection Of Circulating Tumor Cells (CTC) In Patients With NSCLC Undergoing Definitive Radiotherapy Or Chemoradiotherapy
An observational study of Non-small Cell Lung Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
CTC levels collected pre-surgery will be correlated with pathological samples. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Dec 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: NSCLC patients
Who may be able to join
- Patients with biopsy-proven NSCLC who are undergoing definitive radiotherapy as a part of their treatment regimen.
- Age 18 or older
- Signed informed consent
- Patients who are incapable of providing informed consent are excluded from participating in this study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Detection Of Circulating Tumor Cells (CTC) In Patients With Non-small Cell Lung Cancer (NSCLC) Undergoing Definitive Radiotherapy Or Chemoradiotherapy
CTC levels collected pre-surgery will be correlated with pathological samples.
Read the detailed description
Patients with NSCLC who undergo radiation as part of a definitive course of treatment will be enrolled. Blood collections will be obtained before, during, and after radiotherapy. We will collect demographic and treatment data and explore \& describe the pattern of CTC detection in all patients
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Patients with early stage NSCLC undergoing stereotactic radiotherapy Receives: Radiation: Radiotherapy | |
| Cohort 2 | Patients with locally advanced NSCLC undergoing standard chemoradiotherapy Receives: Radiation: Radiotherapy | |
| Cohort 3 | Patients with stage I-III NSCLC undergoing standard, fractionated radiotherapy alone Receives: Radiation: Radiotherapy | |
| Cohort 4 | Patients with locally advanced NSCLC undergoing standard chemoradiotherapy with the novel signal transduction inhibitor, nelfianvir. Receives: Radiation: Radiotherapy | |
| Cohort 5 | Patients with resectable stage IIIa NSCLC undergoing pre-operative chemoradiotherapy Receives: Radiation: Radiotherapy | |
| Cohort 6 | Patients with suspected (no tissue diagnosis) early stage NSCLC undergoing stereotactic radiotherapy Receives: Radiation: Radiotherapy | |
| Cohort 7 | Patients with locally advanced NSCLC undergoing stereotactic radiotherapy followed by concurrent mediastinal chemoradiotherapy Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Describe the Pattern of CTCs Before and After Definitive Radiotherapy for Each Treatment Stratum
The pattern of CTCs before and after definitive radiotherapy for each treatment stratum. CTC counts per mL before and after definitive radiotherapy.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startSep 2012
- Primary completionDec 2019
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Feigenberg, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135679
- Sponsor's protocol ID
- UPCC 12512
- Status last verified
- Nov 2024
- First submitted
- 2 May 2014
- Last updated
- 20 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Evanson D, Griffin M, O'Reilly SE, Johnson T, Werner T, Kothekar E, Jahangiri P, Simone CB 2nd, Swisher-McClure S, Feigenberg SJ, Revheim ME, Zou J, Alavi A. Comparative assessment of radiation therapy-induced vasculitis using [18F]FDG-PET/CT in patients with non-small cell lung cancer treated with proton versus photon radiotherapy. Eur J Nucl Med Mol Imaging. 2024 Apr;51(5):1444-1450. doi: 10.1007/s00259-023-06535-3. Epub 2023 Dec 14.
PubMed 38095673
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Detection Of Circulating Tumor Cells (CTC) In Patients With Non-small Cell Lung Cancer (NSCLC) Undergoing Definitive Radiotherapy Or Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT02135679
- Acronym / sponsor ID
- UPCC 12512
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 12 May 2014 (estimated)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CTC levels collected pre-surgery will be correlated with pathological samples.
Detailed description
Patients with NSCLC who undergo radiation as part of a definitive course of treatment will be enrolled. Blood collections will be obtained before, during, and after radiotherapy. We will collect demographic and treatment data and explore \& describe the pattern of CTC detection in all patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Radiation: RadiotherapyPatients with early stage NSCLC undergoing stereotactic radiotherapy |
| Cohort 2 | – | Radiation: RadiotherapyPatients with locally advanced NSCLC undergoing standard chemoradiotherapy |
| Cohort 3 | – | Radiation: RadiotherapyPatients with stage I-III NSCLC undergoing standard, fractionated radiotherapy alone |
| Cohort 4 | – | Radiation: RadiotherapyPatients with locally advanced NSCLC undergoing standard chemoradiotherapy with the novel signal transduction inhibitor, nelfianvir. |
| Cohort 5 | – | Radiation: RadiotherapyPatients with resectable stage IIIa NSCLC undergoing pre-operative chemoradiotherapy |
| Cohort 6 | – | Radiation: RadiotherapyPatients with suspected (no tissue diagnosis) early stage NSCLC undergoing stereotactic radiotherapy |
| Cohort 7 | – | Radiation: RadiotherapyPatients with locally advanced NSCLC undergoing stereotactic radiotherapy followed by concurrent mediastinal chemoradiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NSCLC patients
Key inclusion criteria (4 listed)
- Patients with biopsy-proven NSCLC who are undergoing definitive radiotherapy as a part of their treatment regimen.
- Age 18 or older
- Signed informed consent
- Patients who are incapable of providing informed consent are excluded from participating in this study.
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 |
|---|---|---|
| Radiotherapy | Radiation | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 |
Primary outcome
To Describe the Pattern of CTCs Before and After Definitive Radiotherapy for Each Treatment Stratum
Time frame: 24 months
The pattern of CTCs before and after definitive radiotherapy for each treatment stratum. CTC counts per mL before and after definitive radiotherapy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38095673Evanson D, Griffin M, O'Reilly SE, Johnson T, Werner T, Kothekar E, Jahangiri P, Simone CB 2nd, Swisher-McClure S, Feigenberg SJ, Revheim ME, Zou J, Alavi A. Comparative assessment of radiation therapy-induced vasculitis using [18F]FDG-PET/CT in patients with non-small cell lung cancer treated with proton versus photon radiotherapy. Eur J Nucl Med Mol Imaging. 2024 Apr;51(5):1444-1450. doi: 10.1007/s00259-023-06535-3. Epub 2023 Dec 14.
Related trials for Non-small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung 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.
Steven Feigenberg, MD principal investigator
Abramson Cancer Center at Penn 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 Non-small Cell Lung Cancer, run by Abramson Cancer Center at Penn Medicine 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 20 Nov 2024. 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?
Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Describe the Pattern of CTCs Before and After Definitive Radiotherapy for Each Treatment Stratum (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02135679, which also lists 1 linked publication.
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 20 Nov 2024.