RECRUITING

Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is an observational study of blood and tissue biomarkers. Investigators plan to evaluate the accuracy of lung cancer biomarkers found in the blood in determining if a lung nodule is cancer or benign. Investigators also plan to examine another biomarker found in the tumor tissue to identify participants after lung cancer surgery who have a high risk for recurrent cancer. Finally, investigators plan to determine if one of the blood-based biomarkers can be used to detect any late cancer recurrence.

Official Title

Using Biomarkers for Diagnosis, Risk Stratification of Post -Treatment Recurrence and Long-Term Surveillance of Lung Cancer

Quick Facts

Study Start:2023-01-11
Study Completion:2028-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05665504

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Potentially-resectable lung nodule 8-40 mm diameter suspected (no preop diagnosis) of being a clinically node-negative lung cancer \[clinical stage IA-IB (cT1a-T2aN0), \<4cm diameter\].
  2. * If surgical resection is recommended, patient will undergo surgery at Moffitt Cancer Center.
  3. * If a definite tissue diagnosis is obtained and stereotactic body radiotherapy (SBRT) is the recommended treatment instead of surgery, the SBRT will be delivered at Moffitt Cancer Center.
  4. * \>18 years old, male or female.
  5. * ECOG performance status 0-1.
  6. * Agree to participate in the follow-up protocol.
  7. * Any suspected primary lung cancer cell type (except a suspected typical carcinoid tumor, carcinoma in situ or minimally-invasive carcinoma).
  8. * Ability to understand and the willingness to sign a written, informed consent document.
  1. * Participants who are actively receiving any cancer treatment.
  2. * Participants with uncontrolled intercurrent illness.
  3. * Prior lung cancer within 5 years.
  4. * Current active other major cancer except non-melanoma skin cancer.
  5. * Patients with pure ground glass opacities (nodules) or hilar masses.
  6. * Suspected typical carcinoid cell type (well-differentiated neuroendocrine carcinoma).
  7. * Metastatic nodule (suspected) in the lung from an extrapulmonary cancer.
  8. * Patient unable to provide informed consent.
  9. * Prisoner or incarcerated individual.
  10. * For surgical patients, a R1 or R2 resection.

Contacts and Locations

Study Contact

Brianna Aponte
CONTACT
813-745-0787
Brianna.Aponte@moffitt.org

Principal Investigator

Lary A Robinson, MD
PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center

Study Locations (Sites)

Moffitt Cancer Center
Tampa, Florida, 33612
United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

  • Lary A Robinson, MD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-11
Study Completion Date2028-02

Study Record Updates

Study Start Date2023-01-11
Study Completion Date2028-02

Terms related to this study

Keywords Provided by Researchers

  • Biomarkers
  • Lung Cancer Biomarkers

Additional Relevant MeSH Terms

  • Lung; Node
  • Adenocarcinoma of Lung