- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT02146170
Kudosten hankinta ja luonnonhistoriallinen tutkimus ihmisistä, joilla on ei-pienisoluinen keuhkosyöpä, pienisoluinen keuhkosyöpä, keuhkojen ulkopuolinen pienisolusyöpä, keuhkojen neuroendokriiniset kasvaimet ja kateenkorvan epiteelisyövän kasvaimet
Kudosten hankinta- ja luonnonhistoriallinen tutkimus potilailla, joilla on ei-pienisoluinen keuhkosyöpä, pienisoluinen keuhkosyöpä, keuhkojen ulkopuolinen pienisolusyöpä, keuhkojen neuroendokriiniset kasvaimet ja kateenkorvan epiteelisyövän kasvaimet
Background:
- Lung cancer is the leading cause of cancer-related death worldwide. It causes more than one million deaths every year. Researchers want to gather tissue samples from people with lung and thymic cancers to understand the disease better. This may lead to new ways to diagnose and treat it.
Objective:
- To collect tissue samples for use in the study of lung cancers.
Eligibility:
- Adults over age 18 with non-small cell lung cancer, small cell lung cancer, extra pulmonary small cell cancer, pulmonary neuroendocrine tumors, and thymic epithelial tumors.
Design:
- Participants will be screened with a medical history, physical exam, and blood tests. They will be asked about how they perform their daily tasks.
- Participants may be asked to give urine and blood samples. They may give a saliva sample if they cannot give blood. They will also give a sample of their tumor from a biopsy they had. They may also be given the option to undergo a biopsy.
- Participants may have MRI, CT, and/or PET scans of the body. They will lie in a machine that takes pictures of the body.
- After visits to the Clinical Center end, researchers will contact participants by phone every year to check on their health.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
Background:
- Lung cancer is the leading cause of cancer-related death worldwide, accounting for more than one million deaths every year.
- Several genetic and epigenetic alterations are involved in initiation and progression of NSCLC. Some of these alterations are seen in normal and pre-neoplastic cells as well, suggesting a sequential development from normal epithelial cells to cancer, through a multistep process, usually coincident with cigarette smoking.
- This natural history protocol is an extension of our Molecular Profiling protocol to enable tissue collection for more in-depth proteomic and genomic analyses to understand tumor biology and treatment response.
- A cohort of patients enrolled in this natural history study is likely to enroll in the IRB approved protocol for end-of-life in-patient hospice and rapid autopsy following death (13-C-0131). Longitudinally collected tumor tissue from these patients, including from several metastatic sites at autopsy will be a unique resource to understand tumor evolution.
- There will be opportunity to embark upon a wide array of studies in the future with the longitudinally collected tissue samples tagged with clinical information from patients.
Objectives:
- To allow sample acquisition for use in the study of non-small cell lung cancer (NSCLC), Small cell lung cancer (SCLC), extrapulmonary small cell cancer (ESCC), pulmonary neuroendocrine tumors (PNET), and thymic epithelial tumors (TETs).
Eligibility:
- Patients with histologically or cytologically confirmed NSCLC, SCLC, ESCC, PNET, and TET.
- Patients consulted in the Clinical Center without a definitive diagnosis, but clinically considered likely to have a thoracic malignancy of the above histologies, pending further tissue acquisition and/or pathology review.
- Age greater than or equal to 18 years.
Design:
- This is a biospecimen collection and natural history protocol in which samples will be collected from patients with NSCLC, SCLC, ESCC, PNET, and TET.
- Eligible patients undergoing screening for or participating in NIH protocols or eligible patients treated elsewhere and referred from other oncologists will be referred for participation in this study.
- Upon providing informed consent, patients will undergo sample acquisition procedures, which may include a tumor biopsy, bone marrow biopsy or the collection of blood, urine or other body fluids.
- An accrual ceiling of 2000 subjects is planned.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Shannon G Swift, R.N.
- Puhelinnumero: (240) 858-3157
- Sähköposti: shannon.swift@nih.gov
Tutki yhteystietojen varmuuskopiointi
- Nimi: Arun Rajan, M.D.
- Puhelinnumero: (240) 760-6236
- Sähköposti: rajana@mail.nih.gov
Opiskelupaikat
-
-
Maryland
-
Bethesda, Maryland, Yhdysvallat, 20892
- Rekrytointi
- National Institutes of Health Clinical Center
-
Ottaa yhteyttä:
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- Puhelinnumero: TTY dial 711 800-411-1222
- Sähköposti: ccopr@nih.gov
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Patients with histologically or cytologically confirmed NSCLC, SCLC, ESCC, PNET, and TET
Kuvaus
- INCLUSION CRITERIA:
- Individuals with histologically or cytologically confirmed NSCLC, SCLC, ESCC, PNET, and TET.
- Individuals consulted in the Clinical Center without a definitive diagnosis, but clinically considered likely to have a malignancy of the above histologies, pending further tissue acquisition and/or pathology review.
- Age greater than or equal to18 years. Children are excluded from the study, as the above thoracic malignancies are rare in this population.
- Ability of subject to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
- Active symptomatic major organ disorder that would increase the risk of biopsy, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, pulmonary dysfunction.
- Active concomitant medical or psychological illnesses that may increase the risk to the subject, at the discretion of the Principal Investigator.
- Known HIV-positive individuals not on combination antiretroviral therapy are ineligible.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: COHORT
- Aikanäkymät: PROSPECTIVE
Kohortit ja interventiot
Ryhmä/Kohortti |
|---|
|
Single group
Patients with histologically or cytologically confirmed NSCLC, SCLC, ESCC, PNET, and TET |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Allow sample acquisition for use in the study of thoracic malignancies except mesothelioma.
Aikaikkuna: Ongoing
|
blood, tumor, body fluids, and normal tissue samples |
Ongoing
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Follow the natural history of patients with thoracic malignancies.
Aikaikkuna: ongoing
|
clinical data, including overall survival |
ongoing
|
|
Conduct genomic, proteomic and immunological analyses on blood, tumor, body fluid and normal tissue in support of NIH translational trials to develop new therapeutic agents and novel treatment approaches as well as new prognostic and diagnostic ...
Aikaikkuna: ongoing
|
Specific studies include, but not limited to genomic analyses using NGS technologies (exome, transcriptome and/or whole genome sequencing), DNA methylation analyses, DNA copy number analyses, proteomic studies including mass spectrometry, capillary Westerns, reverse phase protein microarrays (RPPA), luminex assays, ELISA and IHC, and metabolomics studies using mass spectrometry. |
ongoing
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Arun Rajan, M.D., National Cancer Institute (NCI)
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Weir BA, Woo MS, Getz G, Perner S, Ding L, Beroukhim R, Lin WM, Province MA, Kraja A, Johnson LA, Shah K, Sato M, Thomas RK, Barletta JA, Borecki IB, Broderick S, Chang AC, Chiang DY, Chirieac LR, Cho J, Fujii Y, Gazdar AF, Giordano T, Greulich H, Hanna M, Johnson BE, Kris MG, Lash A, Lin L, Lindeman N, Mardis ER, McPherson JD, Minna JD, Morgan MB, Nadel M, Orringer MB, Osborne JR, Ozenberger B, Ramos AH, Robinson J, Roth JA, Rusch V, Sasaki H, Shepherd F, Sougnez C, Spitz MR, Tsao MS, Twomey D, Verhaak RG, Weinstock GM, Wheeler DA, Winckler W, Yoshizawa A, Yu S, Zakowski MF, Zhang Q, Beer DG, Wistuba II, Watson MA, Garraway LA, Ladanyi M, Travis WD, Pao W, Rubin MA, Gabriel SB, Gibbs RA, Varmus HE, Wilson RK, Lander ES, Meyerson M. Characterizing the cancer genome in lung adenocarcinoma. Nature. 2007 Dec 6;450(7171):893-8. doi: 10.1038/nature06358. Epub 2007 Nov 4.
- Imielinski M, Berger AH, Hammerman PS, Hernandez B, Pugh TJ, Hodis E, Cho J, Suh J, Capelletti M, Sivachenko A, Sougnez C, Auclair D, Lawrence MS, Stojanov P, Cibulskis K, Choi K, de Waal L, Sharifnia T, Brooks A, Greulich H, Banerji S, Zander T, Seidel D, Leenders F, Ansen S, Ludwig C, Engel-Riedel W, Stoelben E, Wolf J, Goparju C, Thompson K, Winckler W, Kwiatkowski D, Johnson BE, Janne PA, Miller VA, Pao W, Travis WD, Pass HI, Gabriel SB, Lander ES, Thomas RK, Garraway LA, Getz G, Meyerson M. Mapping the hallmarks of lung adenocarcinoma with massively parallel sequencing. Cell. 2012 Sep 14;150(6):1107-20. doi: 10.1016/j.cell.2012.08.029.
- Rikova K, Guo A, Zeng Q, Possemato A, Yu J, Haack H, Nardone J, Lee K, Reeves C, Li Y, Hu Y, Tan Z, Stokes M, Sullivan L, Mitchell J, Wetzel R, Macneill J, Ren JM, Yuan J, Bakalarski CE, Villen J, Kornhauser JM, Smith B, Li D, Zhou X, Gygi SP, Gu TL, Polakiewicz RD, Rush J, Comb MJ. Global survey of phosphotyrosine signaling identifies oncogenic kinases in lung cancer. Cell. 2007 Dec 14;131(6):1190-203. doi: 10.1016/j.cell.2007.11.025.
- Wong-Rolle A, Dong Q, Zhu Y, Divakar P, Hor JL, Kedei N, Wong M, Tillo D, Conner EA, Rajan A, Schrump DS, Jin C, Germain RN, Zhao C. Spatial meta-transcriptomics reveal associations of intratumor bacteria burden with lung cancer cells showing a distinct oncogenic signature. J Immunother Cancer. 2022 Jul;10(7):e004698. doi: 10.1136/jitc-2022-004698.
- Fialkoff G, Takahashi N, Sharkia I, Gutin J, Hermoni N, Nirula M, Kumar R, Pongor L, Nichols S, Sciuto L, Parmar K, Desai P, Suresh P, Abel M, El Meskini R, Maoz M, Rottenberg Y, Nevo S, Nechushtan H, Peretz T, Roame D, Hubert A, Cohen JE, Salah A, Temper M, Grinshpun A, Weaver-Ohler Z, Rajan A, Figg WD Sr, Zick A, Sadeh R, Friedman N, Thomas A. Plasma nucleosome profiling reports on tumor burden and molecular subtypes in small cell lung cancer. J Clin Invest. 2026 Oct 1;136(19):e202151. doi: 10.1172/JCI202151. eCollection 2026 Oct 1.
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvioitu)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 140105
- 14-C-0105
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to dbGaP.
IPD-jaon aikakehys
Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol GDS plan for as long as database is active.
IPD-jaon käyttöoikeuskriteerit
Clinical data will be made available via subscription to BTRIS and with the permission of the study PI. Genomic data are made available via dbGaP through requests to the data custodians.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ICF
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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