Clinical trial · Observational
Circulating Tumor Cells in Non-Small Cell Lung Carcinoma
Phase 2 Study of Circulating Tumor Cell in Non-Small Cell Lung Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- CTC Enumeration
- timeFrame
- 3 months from baseline, an average of 2 weeks post patient tissue biopsy
- description
- 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.
Secondary outcomes (3)
- measure
- Lung Cancer Subtyping
- timeFrame
- 3 months from baseline, an average of 2 weeks post patient tissue biopsy
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available