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Recruiting NCT05265429

Biology of Young Lung Cancer Study: The YOUNG LUNG Study

— Observational Non Small Cell Lung Cancer Small Cell Lung Carcinoma NUT Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Data and Specimen Collection.
Who it may be relevant to
Registry conditions: Non Small Cell Lung Cancer, Small Cell Lung Carcinoma, NUT Carcinoma. Basic parameters: from 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed description

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.

Interventions

  • Genetic Data and Specimen Collection
    * 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 t

Primary outcome measures

  • Repository of specimens and data [Time frame: 5 years or study closure]
Secondary outcome measures (3)
  • Number of patients with targetable somatic alterations in known oncogenic driver genes [Time frame: 5 years or study closure]
  • Number of patients with predicted oncogenic alterations in unknown driver genes [Time frame: 5 years or study closure]
  • Number of patients with pathogenic or likely pathogenic germline alterations in known cancer predisposition genes [Time frame: 5 years or study closure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 4 centers
  • Massachusetts General Hospital — Boston
  • Beth Israel Deaconess Medical Center — Boston
  • Brigham and Women's Hospital — Boston
  • Dana-Farber Cancer Institute — Boston

Identifiers

NCT: NCT05265429 · 21-442

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗