DNA Analysis of Blood and Tissue from Patients with Lung... | NCT00471978

Studies
DNA Analysis of Blood and Tissue from Patients with Lung Cancer

NCT00471978

Sponsor

Massachusetts General Hospital

Status

Recruiting

Last Update Posted

Nov 29, 2024Actual

Enrollment

Not provided

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
MGH-1999-P-004935/26	Other Identifier	Partners Institutional Review Board

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

Sep 2005

Primary Completion Date

Sep 2026Estimated

Completion Date

Sep 2026Estimated

First Submitted Date

May 8, 2007

First Submission Date that Met QC Criteria

May 8, 2007

First Posted Date

May 10, 2007Estimated

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 of Enviromental Genetics, Professor of Medicine, 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

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help the study of cancer in the future.

PURPOSE: This clinical trial is analyzing the DNA in blood and tissue samples from patients with lung cancer.

Detailed Description

OBJECTIVES:

Assess the role of genetic polymorphisms in lung-cancer risk in patients with lung cancer.
Assess the role of germline polymorphisms in DNA repair genes, p53 pathway genes, and a matrix metalloproteinase gene (tumor invasion factor) in lung-cancer risk, after adjusting for potential confounders.
Assess the roles of gender and age in the genetic susceptibility of lung cancer.
Assess the role of genetic polymorphisms in modifying the diet-lung cancer risk association (gene-diet and exploratory gene-gender-diet and gene-gene-diet interactions).
Assess the role of polymorphisms on the risk of developing specific histologic subtypes of lung cancer in case-only analyses.
Determine whether continued exposures to mainstream and/or second-hand tobacco smoking is associated with poorer clinical prognosis in patients treated for lung cancer.

OUTLINE: This began as a case-control study, but is currently case only.

Blood samples are collected from patients and controls. Samples are analyzed by polymerase chain reaction for gene polymorphisms. Genes to be studied include GSTP1, GSTM1, GSTT1, ERCC2, XRCC1, EPHX, NAT-2, p53 gene, CYP1A1, NQO1, MnSOD, and GPX1. Tissue samples collected from patients undergoing surgery and blood samples are archived for future studies.

Patients and controls complete questionnaires about diet, medical history, and occupational/environmental history.

PROJECTED ACCRUAL: A total of 3,400 patients and 3,400 controls will be accrued for early phases of this study. Total enrollment to reach 15,000.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Metabolic polymorphisms	to compare differences among lung cancer patients	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Patient:
- Newly diagnosed primary lung cancer
  - Patient at Massachusetts General Hospital (MGH) or Boston Medical Center Cancer Center

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

Not specified

EXCLUSIONS:

Vulnerable populations are excluded. Patients with metastasis from another site to lung or mesothelioma are excluded.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David C. Christiani, MD	Massachusetts General Hospital	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
D002289	Carcinoma, Non-Small-Cell Lung
D055752	Small Cell Lung Carcinoma

Ancestor Terms

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

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Browse Branches

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