Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05265429

Biology of Young Lung Cancer Study: The YOUNG LUNG Study

The purpose of this research study is to learn more about lung cancer (NSCLC or SCLC) diagnosed in adults at ages 45 or younger.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms NUT Carcinoma Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Loading trial locations.

About this study

This research study looks to enroll as many people diagnosed with lung cancer at 45 years old or younger in order to:

  • Better understand causes of lung cancer in individuals 45 years old and younger, which is a rare disease
  • Better estimate lung cancer risks and potential risk factors for lung cancer in individuals 45 years old and younger
  • Examine tumor (somatic) or normal (germline) genetic changes that may be shared among young lung cancer patients
  • Improve opportunities for screening and treatment of lung cancer in individuals 45 years old and younger

Study procedures will include:

  • Collecting information from participants' medical record and two (2) short questionnaires
  • Collecting blood and/or saliva samples
  • Collecting tumor tissue samples (optional)

It is expected that about 500 people will take part in this research study. Participants will be in this study until it closes or the participant withdraws consent.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 45 and under at lung cancer diagnosis
  • Pathologically confirmed bronchogenic lung carcinoma (NSCLC or SCLC of any stage) at any treatment time point
  • Provision of written informed consent
  • Willingness to undergo no more than two (2) peripheral blood draws in a four (4) week period, with no more than 50 ml peripheral blood collected over eight (8) weeks
  • Individuals under age 18 are eligible for study if they meet defined criteria; in addition, consent for participation must be given by a legal guardian or parent

Exclusion criteria

  • Individuals who decline to sign consent
  • Individuals who are unable to give consent or assent and are without a designated healthcare proxy
  • Compromise of patient diagnosis or staging if tissue is used for research

Treatment and study plan

Data and Specimen Collection

Genetic
  • Provide research team access to relevant medical records
  • Answer two (2) short questionnaires at time of consent
  • Provide up to 5 tubes (37 ml) of blood at or near the time of consent, and/or saliva sample
  • Consider consenting to other optional parts of the research such as:
  • Providing additional blood or tissue samples in the future (optional)
  • Providing permission for obtainment of stored tissue specimens from lung cancer surgeries or biopsies from the pathology departments where they have been stored (optional)

Primary outcomes

  1. Repository of specimens and data

    Time frame: 5 years or study closure

    Prospective registry of young lung cancer specimens for exploratory tumor and germline genomics, transcriptomics/proteomics, and future biomarker study.

Secondary outcomes

  1. Number of patients with targetable somatic alterations in known oncogenic driver genes

    Time frame: 5 years or study closure

    Targetable alterations are defined as any somatic alteration in a driver oncogene for which a Food and Drug Administration-approved therapy exists, for which an off-label therapy exists, or for which a clinical trial exists (including but not limited to EGFR, KRAS, ALK, ROS1, RET, MET, BRAF, and TRK). Results will be summarized using descriptive statistics.

  2. Number of patients with predicted oncogenic alterations in unknown driver genes

    Time frame: 5 years or study closure

    Unknown driver genes include genes not currently known to be driver oncogenes in lung cancer, and for which no directed treatment exists. Results will be summarized using descriptive statistics.

  3. Number of patients with pathogenic or likely pathogenic germline alterations in known cancer predisposition genes

    Time frame: 5 years or study closure

    Pathogenic or likely pathogenic variants based on classification by the American College of Medical Genetics and Genomics (ACMG). Results will be summarized using descriptive statistics.

Study contacts

Contact information is provided by the study sponsor or research team.

Pasi A Janne, MD, PhD

CONTACT

[email protected]

617-632-6036

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 3, 2022
Registry last updated
Oct 29, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.