Evaluation of Cell Changes in Blood and Tissue in Cancers of the Lung, Esophagus and Lung Lining

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-120
SponsorNational Cancer Institute (NCI)

About this trial

Background:

* Chromatin is is the structural building block of a chromosome. It is found inside the nucleus of the cell and consists of a complex of DNA and protein. * Cancers of the lung, pleura (lung lining) and esophagus show profound changes in chromatin structure that may affect the course of disease in participants. * A better understanding of these diseases and the genetic changes associated with them may be helpful in developing new treatments for them.

Objectives:

* To medically evaluate individuals with potential (medically suspicious) or proven cancer of the lung, esophagus, pleura, mediastinum or chest wall, or cancers of other origin that have invaded the lung, and then, to determine eligibility for NCI investigational treatment studies for participants \>18 years of age (adult participants only). * To use clinically obtained biopsies (small pieces of tissue) of tumor and adjacent normal tissue from clinically indicated procedures (standard of care biopsy or surgery), as well as blood and urine samples, from participants with cancer of the lung, esophagus, pleura, mediastinum or chest wall, or cancers of other origin that have invaded the lung, for research into immune and cellular changes of these cancers. Study research includes genetic testing and the growth of laboratory cell lines from participant samples, to examine how genes change drug metabolism. * To permit long-term follow-up of participants with cancer of the lung, esophagus, pleura, mediastinum or chest wall, or cancers of other origin that have invaded the lung, for natural history research on genetics and if the gene expression coincides with clinical response to patient anti-cancer therapies (treatment received at NCI or from participant's own physicians).

Eligibility:

* Individuals 2 years of age and older with potential (medically suspicious) or proven cancer of the lung, esophagus, pleura, mediastinum or chest wall, or cancers of other origin that have invaded the lung. Note: Individuals \>= 2 years of age and under 18 years of age may only participate in research sample collection if the tissue acquisition is performed during a clinically indicated surgical procedure, and the sampling of tissue, blood or urine does NOT add risk to the clinically indicated procedures. * Participants must have physical examination parameters within acceptable limits by standard of practice guidelines prior to clinically indicated surgical procedure (standard of care biopsy or surgery).

Design:

* All participants will undergo standard tests to evaluate the stage of their disease, and then, eligibility determination for NCI investigational treatment studies will be made for participants \>18 years of age (adult participants only).

* Participants \>18 years of age (adult participants only) who are determined to be eligible for a treatment study at NCI are offered participation in that study. No investigational treatment is administered on this protocol. * Participants \>= 2 years of age (all participants) may receive standard of care treatment at NCI or with their own physician if it is determined that standard of care surgery, radiation, or chemotherapy is more clinically appropriate for that participant's disease status. * Participants who receive standard of care biopsy or surgery (clinically indicated standard staging, surgical intervention, and follow up care) at the NIH Clinical Center are expected to return for a clinical examination visit post-procedure (for instance, 4 weeks after discharge from surgery). After recovery, participants will return to the NIH Clinical Center for study follow-up visits at intervals based on their clinical status (such as every 3 to 36 months) until the end of study participation. * Blood and urine samples are collected from all participants for study research at baseline and study visits until the end of study participation. If participants have additional clinically indicated biopsies or surgeries, resected tissue may be collected for study research (as logistically appropriate). * It is expected that up to 1,559 participants will be enrolled and followed long-term on this study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

primary clinical@@@

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,559 Participants
are grouped into 1 trial group
Group A: 1/Cohort 1

Trial outcomes

Primary outcomes

1

Permit long-term follow-up of study participants for research to ascertain if gene expression and DNA methylation profiles coincide with response to therapy

Long-term follow-up visits at intervals based on participant's clinical status, to include history and medical exam, collection of research blood and urine; additional tissue from clinically indicated surgery/biopsy may be collected if available

Time frame
open-ended
2

Permit evaluation of adult patients referred to the Thoracic Surgery Branch, NCI in order to identify individuals who will be suitable candidates for treatment/intervention protocols

Evaluation of adult patients referred to the Thoracic Surgery Branch, NCI in order to identify individuals who will be suitable candidates for treatment/intervention research protocols

Time frame
open-ended
3

Obtain specimens for research from study participants

Specimens for research (tumor and adjacent normal tissues from clinically indicated biopsy or surgery, and blood, urine); research samples may be used for germline testing and ex vivo cell lines (autologous tumor cell lines and EBV-transformed B cell lines)

Time frame
open-ended

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.