Clinical trial · Observational
Genetic Epidemiology of Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will search for genes that greatly increase the risk of developing lung cancer in conjunction with cigarette smoking or other environmental agents, or both. Lung cancer is the second most common cancer diagnosed among men and women and the leading cause of cancer death in the United States. It has been frequently given as an example of cancer determined only by the environment, certain occupations, and dietary habits. Yet researchers have long had a hypothesis that people vary in their risk of becoming affected when exposed to these factors. Also, some evidence has shown that lung cancer in families may be due to the combined effects of inheritance of a major gene and cigarette smoking. Individuals who have a confirmed diagnosis of lung cancer or a family history of lung cancer may be eligible to enroll their families in the study. Family members will be asked to do one or more of the following: * Complete a questionnaire about personal medical history, lifestyle, and diet. * Have blood drawn from a vein in the arm. * If a family member has had a biopsy or is scheduled for one, give permission to obtain medical records and a portion of the stored tissue. * If any relatives have died of cancer, sign a release form to allow researchers to get copies of medical and pathology records, and tissue samples from surgery. If the family members agree, they may be recontacted to answer questions about their health and those of their family, during an annual telephone conversation. Follow-up questionnaires may be sent to participants, to determine if any new cancers have developed in the family. In the event of a new cancer, the classification of the family may change from the low-risk to intermediate risk-level and from the intermediate-risk to high-risk level. Follow-up will continue, to get information about tumors and death. Also, a newsletter for lung cancer families will occasionally be distributed to participants. In the future, the Internet will also provide information for families.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- High risk lung cancer families
- description
- Individuals from families with a high risk of lung cancer, both affected and unaffected family members
Primary outcomes (1)
- measure
- Determine whether there are genetic variants contributing to lung cancer risk
- timeFrame
- ongoing
- description
- Determine whether there are genetic variants contributing to lung cancer risk
Secondary outcomes (1)
- measure
- Determine whether there are gene-gene or gene-environment interactions contributing to lung cancer risk
- timeFrame
- ongoing
- description
- Determine whether there are gene-gene or gene-environment interactions contributing to lung cancer risk
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
Show eligibility criteria text
* INCLUSION CRITERIA: All individuals with a histologically confirmed diagnosis of lung cancer or a family of lung cancer are eligible to enroll their family in the study. Five major histologic types of lung cancer, i.e., adenocardinoma, squamous cell, small cell, large cell, and unspecified nonsmall cell carcinoma will be included. In addition to lung cancer patients, LSU will also contact patients newly diagnosed with bronchus or tracheal cancer in target hospital areas to request their enrollment in their study. In addition, several sites including LSU, Mayo Clinic and Karmanos Cancer Institute also collect DNA samples from unaffected, geographically and ethnically matched controls. For the purposes of this study, an eligible family must meet the minimum criteria for familial lung cancer: at least 2 first-degree relatives in the family have had lung cancer. Priority will be given to more highly loaded pedigrees and to families in which the affected persons had onset of the disease at an early age (less than 50 years). Lung cancer cases may be living or deceased. Relatives with lung cancer are defined as first- o second-degree relatives or cousins of index cases will be eligible to participate in the study because their familial relationships might provide useful linkage information. Adult participants must be physically able to tolerate removal of 25 to 40 ml of blood, or buccal brush sampling of their cheek. Children above 5 years old must be able to physically tolerate an amount of blood drawn that is equal to 4ml/kg of their weight. Adults must be willing to complete a self-administered environmental exposure questionnaire, and all participants must be able to consent to the study procedures (or have appropriate assent/parental consent). Biological specimens, including blood samples, archived tumor blocks and other medical records will be obtained from patients treated at the various hospitals and collection sites and from individuals with strong family history of lung cancer (either affected or unaffected) who have either been self-referred or physician referred to the study. EXCLUSION CRITERIA: Excluded from the study are families or individuals within the family who do not meet the minimum criteria described above. Individuals who do not sign the Consent Form will be excluded, and families for whom all necessary members do not sign the Consent Form may be excluded. MAYO also excludes patients who (1) do not speak English, (2) are non-US citizens or residents and (3) are diagnosed with an uncommon tumor type that is not among the above specified types (e.g.) mixed cell or unspecified non-small cell lung cancer, carcinoids, sarcomas and lymphomas of the lung and bronchus). This is done at MAYO because the family study is piggy-backed onto a case-control study. No fetuses, prisoners or institutionalized individuals will be enrolled. While this study does not target pregnant women, because contact with many of the families will be by mail we will not be able to exclude pregnant women. Additionally, the participant's own physician or health care clinic will draw blood samples from long-distance participants and therefore can determine if there is any risk to the woman or her fetus. UMHS also excludes children as research participants in their site.
References
Publications (0)
Data not yet available