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Active, Not Recruiting

NCT Number: NCT06074133

A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules

This is a prospective, multicenter observational study aim at estimating the potential clinical utility of the CBM and at establishing the SOPs and protocols for a future randomized control trial.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pulmonary Nodule

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rocky Mountain Regional VA Medical Center, Aurora, Colorado, United States

Loading trial locations.

About this study

Objectives:

  • To obtain the combined biomarker model (hs-CYFRA 21-1, radiomics, Mayo) score in a prospective observational trial and estimate potential clinical utility compared to the Mayo Model.
  • To establish standard operating procedures (SOPs) and protocols in a prospective observational trial in anticipation of a future randomized control trial. These include the REDCAP data input protocols, the radiomic protocols, blood draws in the CLIA environment, and estimating the CBM score in a time reasonable for clinical practice (< 2 weeks).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults > 21 y/o
  • IPNs 8-30mm referred for evaluation Figure 4. AUC and reclassification of Combined Biomarker Model
  • Intermediate risk IPN defined as 10-70% risk after applying Mayo risk predictor model
  • Solid nodules or part-solid nodules with solid component >=8mm
  • CT scan with nodule of concern performed within 60 days of enrollment

Exclusion criteria

Pure ground glass nodule or subsolid nodule with solid component <8mm

  • Currently on therapy for any cancer
  • History of primary lung cancer within the last 5 years
  • Multiple nodules highly suspicious for metastatic disease
  • Other malignancy within the last 2 year - Excluding skin cancer other than melanoma
  • Pregnant women
  • Prisoners
  • Inability to provide informed consent
  • Serologic evidence of active fungal infection

Treatment and study plan

Blood Collection

Procedure

Undergo blood draw

Chest Computed Tomography

Procedure

Undergo standard of care chest Computed Tomography

Primary outcomes

  1. The proportion of patients with benign disease who underwent invasive diagnostic procedures.

    Time frame: Up to approximately 2 years

  2. The time to diagnosis (in days) for patients with cancer.

    Time frame: Up to approximately 2 years

  3. Measure time needed to provide the CBM Value to clinician

    Time frame: Up to approximately 2 years

    Number of days

  4. Measure time needed to obtain hs CYFRA 21-1 values

    Time frame: Up to approximately 2 years

    Number of hours (days)

  5. Measure time needed to perform radiomics

    Time frame: Up to approximately 2 years

    Number of hours (days)

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules A Multicenter Prospective Observational Pilot Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2029
First posted
Oct 10, 2023
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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