Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer

Learn more about:
Related Clinical Trial
Recurrence After Whipple’s (RAW): Retrospective Cohort Study Investigating Patterns of Cancer Recurrence Following Pancreaticoduodenectomy for Pancreatic Head Malignancy Implementing Acupuncture and Chinese Herbal Medicine Into Palliative Care Prospective Evaluation of Biliary Tissue Sampling With ERCP Combination of Trametinib (MEK Inhibitor) and Hydroxychloroquine (HCQ) (Autophagy Inhibitor) in Patients With KRAS Mutation Refractory Bile Tract Carcinoma (BTC). DNA Methylation Biomarker for Diagnosis of Cholangiocarcinoma in Patients With Bile Duct Stricture Liver Cancer Registry Platform Target Rare Cancer Knowledge Neoadjuvant Therapy in Biliary Adenocarcinoma BOLD-100 in Combination With FOLFOX for the Treatment of Advanced, Solid Tumours the Impact of Early Palliative Care on the Survival of Locally Advanced and / or Metastatic Cholangiocarcinoma Patients Nutritional Preferences and Product Accessibility in Oral Nutritional Supplements in Participants With Breast, Colorectal, Upper Gastrointestinal, or Prostate Cancer High Volume Washing of the Abdomen in Increasing Survival After Surgery in Patients With Pancreatic Cancer That Can Be Removed by Surgery Short-term Starvation vs. Normal Diet Before Chemotherapy of Solid Tumors Evaluation of MRI Sequences for Ultra-rapid Acquisition of Bile Ducts Images Study of Oral Ceritinib in Patients With ALK and ROS1 Activated Gastrointestinal Malignancies Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer Improving Outcomes in Cancer Patients With a Nutritional and Physical Conditioning Prehabilitation Program 18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant A Clinical Trial to Evaluate Safety and Efficacy of Endovascualr Denervation in Treatment of Cancer Pain Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery Efficacy of Fistulotomy for Biliary Cannulation A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors Etomidate vs. Midazolam for Sedation During ERCP Loop-tipped Guidewire in Selective Biliary Cannulation Pancreatic Head and Peri-ampullary Cancer Laparoscopic vs Open Surgical Treatment Trial (PLOT) Effects of OXY111A in Primary and Secondary Hepato-Pancreato-Biliary Neoplasm BKM120 in Cancers With PIK3CA Activating Mutations A First-in-human Phase Ia/b, Open Label, Multicentre, Dose Escalation Study of BI 905711 in Patients With Advanced Gastrointestinal Cancers Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations Changes in Liver Function After Stereotactic Body Radiation Therapy Measured by PET/CT PTFE Stents for Treatment of Malignant Biliary Strictures Irreversible Electroporation of Unresectable Liver Tumors Personal Resilience Empowerment Program Study Radiofrequency Ablation for Biliopancreatic Malignancy Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors National Translational Science Network of Precision-based Immunotherapy for Primary Liver Cancer In Vitro Models of Liver and Pancreatic Cancer Biliary Tissue Sampling Using a Cytology Brush or the GIUM Catheter Evaluation of Stereotactic Radiosurgery For Liver Malignancies Beacon BNX™ Endoscopic Ultrasound (EUS)-Needle vs SharkCore™ Needle A Pilot Study to Assess Theragnostically Planned Liver Radiation With Functional DVH Analysis to Optimize Individualized Radiation Therapy Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies Accuracy of Endoscopic Ultrasound for Detection of Tumors of the Liver Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD Margin Status After Pancreaticoduodenectomy for Cancer A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC) Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors Comparison Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies in Biliary Strictures Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy A Study of BBI503 in Adult Patients With Advanced Hepatobiliary Cancer A Study of TRK-950 in Patients With Advanced Solid Tumors Combined HCC-MFCCC Proton Therapy and Bevacizumab for Primary Liver Tumors Effects of Preoperative Immunonutrition in Patients Undergoing Hepatectomy Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic Metastases Fluorescence QRH-882260 Peptide Imaging in the Bile Duct A Phase 1 Study of ZSP1241 in Participants With Advanced Solid Tumors pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin Radiation Therapy in Treating Patients With Hepatocellular Carcinoma, Cholangiocarcinoma, or Liver Metastasis Who Have Impaired Liver Function Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer MRCP Diagnoses EHCC Better When Combined DWI Safety and Efficacy of Modified Folfirinox Versus Gemcis in Bile Duct Tumours Comparison of Biliary Forceps Biopsy and Brush Cytology Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers Pilot Study of Irreversible Electroporation (IRE) to Treat Metastatic Liver Cancer & Cholangiocarcinoma Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers Cyclooxygenase-2 Inhibitor for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer Endobiliary RFA for Unresectable Malignant Biliary Strictures A Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma Clinical Effect and Safety of PDT and RFA for Unresectable EHCC Safety and Efficiency of Photodynamic Therapy for Blie Duct Carcinoma Gemcitabine With Peptide Vaccine Therapy in Treating Patients With Bile Duct Cancer A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma Trial of IRE in Cholangiocarcinoma Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma Chemo Alone or in Combination With Radiation in Unresectable Cholangiocarcinoma ASLAN001 in Patients With Advanced or Metastatic Cholangiocarcinoma Who Progressed on at Least 1 Line of Systemic Therapy A Study of Gemcitabine as an Adjuvant Treatment for Cholangiocarcinoma After Surgical Resection Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer S-1 in Combination With Abraxane in Treating Cholangiocarcinoma Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Cholangiocarcinoma Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations A Phase I/II Safety and Efficacy Study of PCI of Gemcitabine and Chemotherapy in Patients With Cholangiocarcinomas Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma Diagnosis, Treatment Status and Prognosis of Cholangiocarcinoma in China: a Multicenter, Two-way, Non-intervention Study Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy – (FIGHT-202) Pemigatinib in Treating Patients With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma Chart Review: Unresectable/Metastatic Cholangiocarcinoma Treated With Irinotecan, Capecitabine and Celecoxib Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma Study Of Intrahepatic Arterial Injection of 90-Y Glass Microspheres for Cholangiocarcinoma Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma Gemcitabine, Oxaliplatin and Capecitabine in Patients With Advanced Cholangiocarcinoma Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol Study of Pembrolizumab and Olaparib in Bile Duct Cancer Cohort of Patients With Hepatocellular Carcinoma or Cholangiocarcinoma Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma ncRNAs in Exosomes of Cholangiocarcinoma Single Arm Study of RAD001 as Monotherapy in Treatment in Advanced Cholangiocarcinoma Trial of Therapeutic Vaccine in Patients With Cholangiocarcinoma

Brief Title

Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer

Official Title

Tumor, Normal Tissue and Specimens From Patients Undergoing Evaluation or Surgical Resection of Solid Tumors

Brief Summary

      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.

      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.
    

Detailed Description

      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.

      OBJECTIVES:

      - To collect biologic samples from patients 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:

        -  Patients greater than or equal to 18 years of age with radiographic evidence 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.

        -  Patients 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.

        -  Patients 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 1000 patients will be enrolled over a period of 10 years.
    


Study Type

Observational


Primary Outcome

Collection of biologic samples from patients undergoing diagnostic or therapeutic interventions for premalignant, primary or metastatic solid tumors for the purpose of identifying novel molecular and biologic therapeutic targets

Secondary Outcome

 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.

Condition

Colorectal Neoplasms


Study Arms / Comparison Groups

 1/Cohort 1
Description:  Subjects with or without solid tumors in whom diagnostic, preventative, or therapeutic intervention is being performed

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

1000

Start Date

July 21, 2013

Completion Date

December 31, 2027

Primary Completion Date

June 30, 2027

Eligibility Criteria

        -  INCLUSION CRITERIA

          -  Patients must be greater than or equal to 18 years of age.

          -  Patients 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

          -  Patients 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.

          -  Patients should have laboratory and physical examination parameters within acceptable
             limits prior to biopsy or surgery.

          -  Patients must be planning to undergo surgery or biopsy as part of their normal
             treatment plan.

          -  Ability of subject to understand and the willingness to sign a written informed
             consent document.

        EXCLUSION CRITERIA:

        None
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jeremy L Davis, M.D., (240) 760-7533, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01915225

Organization ID

130176

Secondary IDs

13-C-0176

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Jeremy L Davis, M.D., Principal Investigator, National Cancer Institute (NCI)


Verification Date

September 29, 2020