Molecular and Genetic Analysis of Lung Cancer | NCT03029325

Studies
Molecular and Genetic Analysis of Lung Cancer

NCT03029325

Sponsor

Massachusetts General Hospital

Status

Recruiting

Last Update Posted

Nov 29, 2024Actual

Enrollment

15,000Estimated

Phase

Not provided

Conditions

Lung Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
5P30CA006516-50	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1993

Primary Completion Date

Sep 2026Estimated

Completion Date

Sep 2026Estimated

First Submitted Date

Sep 30, 2015

First Submission Date that Met QC Criteria

Jan 20, 2017

First Posted Date

Jan 24, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2024

Last Update Posted Date

Nov 29, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Christopher Christiani, Elkan Blout Professor at Harvard TH Chan School of Public Health, Professor of Medicine Harvard Medical School, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Investigators use a genome-wide approach within a case-control design to identify SNPs that show evidence of association with lung cancer risk and survival.

Detailed Description

Investigators also investigate how genetic variants may affect cancer treatment, at various stages of disease development, in order to determine prognostic and predictive factors for survival.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

15,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival among patients at different stages of lung cancer and treatment will be measured using questionnaires along with medical chart data to monitor treatment and disease progression	Study lung cancer development in a case control study. We will look at three separate outcome measures specified below	20 years

Secondary Outcomes

Measure	Description	Time Frame
Overall survival	Measurement from time of diagnosis to death will be obtained	20 years
Progression-free survival	Time of diagnosis to disease progression (measured by metastasis)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy controls: participants without evidence of any cancer
cases: pathology proven primary lung cancer

Exclusion Criteria:

younger than 18 years old

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Lung cancer cases and healthy controls are recruited from Massachusetts General Hospital patient population. Cases come from Thoracic Surgery or Cancer Center. Controls are usually spouses or friends of cases, or in some cases unrelated to a specific case.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David Christiani, MD	Contact	617-726-9274		dchris@hsph.harvard.edu
Andrea Shafer, MPH	Contact	6177269274		ashafer@mgh.harvard.edu

Overall Officials

Name	Affiliation	Role
David C Christiani, MD	Harvard TH Chan School of Public Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital	Recruiting	Boston	Massachusetts	02114	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided