Clinical trial NCT05265429: Biology of Young Lung Cancer Study: The YOUNG LUNG Study
Official title: Biology of Young Lung Cancer Study: The YOUNG LUNG Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Small Cell Lung Cancer
Small Cell Lung Carcinoma
NUT Carcinoma
Keywords: Non Small Cell Lung Cancer
Small Cell Lung Carcinoma
Genetics
Genomics
Young lung cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 500
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Adults age 45 or under at time of non-small lung cancer (NSCLC) or small cell lung cancer (SCLC) diagnosis

Brief summary: 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.

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

Primary outcomes:
measure: Repository of specimens and data
timeFrame: 5 years or study closure
Secondary outcomes:
measure: Number of patients with targetable somatic alterations in known oncogenic driver genes
timeFrame: 5 years or study closure
measure: Number of patients with predicted oncogenic alterations in unknown driver genes
timeFrame: 5 years or study closure
measure: Number of patients with pathogenic or likely pathogenic germline alterations in known cancer predisposition genes
timeFrame: 5 years or study closure
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Pasi A Janne, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: