Obtention de tissus tumoraux solides de personnes subissant une biopsie ou une intervention chirurgicale pour certains types de cancer
Tumeur, tissus normaux et échantillons de patients subissant une évaluation ou une résection chirurgicale de tumeurs solides
Background:
- Recent advances in cancer research have led to new therapies to treat the disease. It is important to continue these advances and discover new ones. To do that, researchers need tissue samples from solid tumors. This study will collect such samples from people already scheduled to have a procedure at the National Institutes of Health Clinical Center (NIHCC).
Objectives:
- To collect tissue samples for use in studying new ways to treat tumors.
Eligibility:
- Adults 18 years and older, with a precancerous or cancerous solid tumor who are scheduled to have surgery or a biopsy at the NIHCC.
- Children under the age of 18 but who are older than 2 years of age are eligible to be enrolled on the research sample collection portion of this study if they will have a biopsy or surgery as part of their medical care.
Design:
- Before their procedure, participants will have a small blood sample taken.
- Some participants will undergo leukapheresis. In this procedure, blood is removed through a tube in one arm and circulated through a machine that removes white blood cells. The blood, minus the white blood cells, is returned through a tube in the other arm. The procedure takes 3-4 hours.
- For all participants, during the surgery or biopsy, pieces of the tumor and pieces of normal tissue near it will be removed for this study. The rest of the tumor or precancerous growth will be sent to a lab for analysis.
- Participants will return to the clinic about 6 weeks after the operation for a routine checkup. Some may have to return for additional follow-up.
Aperçu de l'étude
Statut
Description détaillée
Background:
Recent advances and insights into the molecular pathogenesis of cancer have led to the development of novel molecular and biologic targeted therapies for the treatment of advanced cancer patients. A critical challenge in extending these studies involves the identification and validation of new therapeutic targets for future cancer therapies.
As Surgical Oncologists at the NCI, we have an interest in identifying novel molecular and biologic targets to facilitate the development of future cancer therapies. In addition, we have the primary responsibility for providing surgical consultative services to the NIH. As such, we are uniquely positioned to acquire and perform important studies on solid tumor tissue to help identify therapeutic targets that may have significant clinical ramifications.
Objective:
To collect biologic samples from participants undergoing diagnostic, preventative, or therapeutic interventions for premalignant, primary or metastatic solid tumors for the purpose of identifying novel molecular and biologic therapeutic targets.
Eligibility:
Participants age >= 2 years and older with radiographic or clinical suspicion of, genetic predisposition for, biochemical evidence of, or histologically/cytologically proven solid neoplasms who require diagnostic, preventative, or therapeutic intervention as a part of the diagnosis and/or treatment and/or follow up for their neoplasm. Note: Participants >= 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 biospecimen sampling (resected tumor tissue, blood, urine, ascites, or bile) does not add risk to the clinically indicated procedures.
Participants without solid tumors in whom a diagnostic, preventative, or therapeutic intervention is being performed, but for whom surgical quality and safety outcomes data are generated.
Participants should have laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to planned intervention.
Design:
A tissue acquisition trial in which tissues will be obtained at the time of intervention.
No investigational therapy will be given.
It is anticipated that 1,764 participants will be followed on this study.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Jonathan M Hernandez, M.D.
- Numéro de téléphone: (240) 760-6072
- E-mail: jonathan.hernandez@nih.gov
Sauvegarde des contacts de l'étude
- Nom: Cathleen E Hannah, C.R.N.P.
- Numéro de téléphone: (240) 858-7006
- E-mail: foregut@mail.nih.gov
Lieux d'étude
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Maryland
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Bethesda, Maryland, États-Unis, 20892
- Recrutement
- National Institutes of Health Clinical Center
-
Contact:
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- Numéro de téléphone: TTY dial 711 800-411-1222
- E-mail: ccopr@nih.gov
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
primary clinical
La description
- INCLUSION CRITERIA:
- Participants must be 2 years of age or older. Note: Participants greater than or equal to 2 and < 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 biospecimen sampling (e.g., blood, urine, ascites, bile, or [clinically indicated] resected tumor tissue) does not add risk to the clinically indicated procedures.
- Participants who have premalignant, primary, or metastatic solid tumors based upon either radiographic or clinical suspicion, biochemical testing, a genetic predisposition, or histological/cytological analysis that requires surgery or biopsy as part of the diagnosis, prevention, treatment, and/or follow-up.
- Participants without solid tumors in whom a diagnostic, preventative, or therapeutic intervention is being performed, but for whom surgical quality and safety outcomes data are generated.
- Participants should have laboratory and physical examination parameters within acceptable limits prior to biopsy or surgery.
- Participants must be planning to undergo surgery or biopsy as part of their normal treatment plan.
- Ability of participant, parent/guardian or legally authorized representative (LAR) to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
None.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
|---|
|
1/ Cohort 1
Participants with or without solid tumors in whom diagnostic, preventative, or therapeutic intervention is being performed |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Collection of biologic samples from participants undergoing diagnostic or therapeutic interventions for premalignant, primary or metastatic solid tumors for the purpose of identifying novel molecular and biologic therapeutic targets
Délai: 2 month
|
Identification of novel molecular and biologic therapeutic targets |
2 month
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Collection of detailed history, demographic, treatment data, and perioperative outcomes data related to surgical quality and safety in order to categorize and track the specific procedures.
Délai: 10 years
|
Detailed history, demographic, treatment data, and perioperative outcomes data related to surgical quality and safety in order to categorize and track the specific procedures. |
10 years
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jonathan M Hernandez, M.D., National Cancer Institute (NCI)
Publications et liens utiles
Publications générales
- Longo DL. Tumor heterogeneity and personalized medicine. N Engl J Med. 2012 Mar 8;366(10):956-7. doi: 10.1056/NEJMe1200656. No abstract available.
- Yachida S, Jones S, Bozic I, Antal T, Leary R, Fu B, Kamiyama M, Hruban RH, Eshleman JR, Nowak MA, Velculescu VE, Kinzler KW, Vogelstein B, Iacobuzio-Donahue CA. Distant metastasis occurs late during the genetic evolution of pancreatic cancer. Nature. 2010 Oct 28;467(7319):1114-7. doi: 10.1038/nature09515.
- Gerlinger M, Rowan AJ, Horswell S, Math M, Larkin J, Endesfelder D, Gronroos E, Martinez P, Matthews N, Stewart A, Tarpey P, Varela I, Phillimore B, Begum S, McDonald NQ, Butler A, Jones D, Raine K, Latimer C, Santos CR, Nohadani M, Eklund AC, Spencer-Dene B, Clark G, Pickering L, Stamp G, Gore M, Szallasi Z, Downward J, Futreal PA, Swanton C. Intratumor heterogeneity and branched evolution revealed by multiregion sequencing. N Engl J Med. 2012 Mar 8;366(10):883-892. doi: 10.1056/NEJMoa1113205.
- Remmert K, Lin Y, Rainey A, Garmendia-Cedillos MA, Perati SR, Davis JL, Blakely AM, Hernandez JM. Three-Dimensional Imaging of Tumor-Bearing Tissue Using the Iterative Bleaching Extends Multiplexity Approach. J Vis Exp. 2025 Apr 25;(218). doi: 10.3791/67869.
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimé)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système endocrinien
- Tumeurs par site
- Tumeurs
- Maladies intestinales
- Tumeurs par type histologique
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies du système digestif
- Maladies gastro-intestinales
- Maladies de l'estomac
- Tumeurs intestinales
- Maladies rectales
- Tumeurs des glandes endocrines
- Maladies pancréatiques
- Maladies des voies biliaires
- Tumeurs, glandulaires et épithéliales
- Adénocarcinome
- Maladies du côlon
- Carcinome
- Maladies des voies biliaires
- Tumeurs des voies biliaires
- Tumeurs de l'estomac
- Tumeurs colorectales
- Tumeurs pancréatiques
- Cholangiocarcinome
- Tumeurs des voies biliaires
Autres numéros d'identification d'étude
- 130176
- 13-C-0176
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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.
Délai de partage IPD
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.
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
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