## Protocol Section
### Identification Module
**NCT ID:** NCT02135679

**Brief Title:** The Detection Of Circulating Tumor Cells (CTC) In Patients With NSCLC Undergoing Definitive Radiotherapy Or Chemoradiotherapy

**Official Title:** The Detection Of Circulating Tumor Cells (CTC) In Patients With Non-small Cell Lung Cancer (NSCLC) Undergoing Definitive Radiotherapy Or Chemoradiotherapy

#### Organization Study ID Info
**ID:** UPCC 12512
#### Organization
**Class:** OTHER
**Full Name:** Abramson Cancer Center at Penn Medicine
### Status Module
#### Completion Date
**Date:** 2023-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-03-01

**Type:** ACTUAL

**Last Update Submit Date:** 2023-02-28

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2019-12

**Type:** ACTUAL

#### Start Date
**Date:** 2012-09

**Status Verified Date:** 2023-02

#### Study First Post Date
**Date:** 2014-05-12
**Type:** ESTIMATED
**Study First Submit Date:** 2014-05-02
**Study First Submit QC Date:** 2014-05-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Abramson Cancer Center at Penn Medicine

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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

### Conditions Module

**Conditions:**

- Non-small Cell Lung Cancer

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 153

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with early stage NSCLC undergoing stereotactic radiotherapy

**Intervention Names:**

- Radiation: Radiotherapy

**Label:** Cohort 1

#### Arm Group 2

**Description:** Patients with locally advanced NSCLC undergoing standard chemoradiotherapy

**Intervention Names:**

- Radiation: Radiotherapy

**Label:** Cohort 2

#### Arm Group 3

**Description:** Patients with stage I-III NSCLC undergoing standard, fractionated radiotherapy alone

**Intervention Names:**

- Radiation: Radiotherapy

**Label:** Cohort 3

#### Arm Group 4

**Description:** Patients with locally advanced NSCLC undergoing standard chemoradiotherapy with the novel signal transduction inhibitor, nelfianvir.

**Intervention Names:**

- Radiation: Radiotherapy

**Label:** Cohort 4

#### Arm Group 5

**Description:** Patients with resectable stage IIIa NSCLC undergoing pre-operative chemoradiotherapy

**Intervention Names:**

- Radiation: Radiotherapy

**Label:** Cohort 5

#### Arm Group 6

**Description:** (Patients with suspected (no tissue diagnosis) early stage NSCLC undergoing stereotactic radiotherapy)

**Intervention Names:**

- Radiation: Radiotherapy

**Label:** Cohort 6

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cohort 1

- Cohort 2

- Cohort 3

- Cohort 4

- Cohort 5

- Cohort 6

**Name:** Radiotherapy

**Type:** RADIATION

### Outcomes Module

#### Primary Outcomes

**Measure:** Circulating tumor cells will be detected by imaging for green fluorescent protein (GFP) which measures cells which high levels of telomerase activity after adenovirus transduction. CTCs are measured in units of number of GFP-positive cells /mL.

**Time Frame:** 24 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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.

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** NSCLC patients

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Philadelphia

**Country:** United States

**Facility:** Abramson Cancer Center of the University of Pennsylvania

**State:** Pennsylvania

**Zip:** 19104

#### Overall Officials

**Official 1:**

**Affiliation:** Abramson Cancer Center at Penn Medicine

**Name:** Samuel Swisher McClure, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000002283

- Term: Carcinoma, Bronchogenic

- ID: D000001984

- Term: Bronchial Neoplasms

- ID: D000009362

- Term: Neoplasm Metastasis

- ID: D000009385

- Term: Neoplastic Processes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M11172

- Name: Lung Neoplasms

- Relevance: HIGH

- As Found: Lung Cancer

- ID: M5546

- Name: Carcinoma, Non-Small-Cell Lung

- Relevance: HIGH

- As Found: Non-Small Cell Lung Cancer

- ID: M12305

- Name: Neoplastic Cells, Circulating

- Relevance: HIGH

- As Found: Circulating Tumor Cells

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5540

- Name: Carcinoma, Bronchogenic

- Relevance: LOW

- As Found: Unknown

- ID: M5260

- Name: Bronchial Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: LOW

- As Found: Unknown

- ID: M12330

- Name: Neoplastic Processes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008175

- Term: Lung Neoplasms

- ID: D000002289

- Term: Carcinoma, Non-Small-Cell Lung

- ID: D000009360

- Term: Neoplastic Cells, Circulating

### Misc Info Module

#### Submission Tracking

- Estimated Results First Submit Date: 2024-04-10

##### Submission Infos

- MCP Release N: Unknown

- Release Date: 2024-04-10

- Reset Date: Unknown

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- Version Holder: 2024-05-24
