Recruiting

Observational Study

Sponsor:

National Cancer Institute LAO

Code:

NCT02474160

Conditions

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Metastatic Malignant Solid Neoplasm

Recurrent Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Cytology Specimen Collection Procedure

Study Details

Brief summary:

This study collects and stores tissue and blood samples from patients with cancer. Collecting and storing samples of tissue and blood from patients with cancer to study in the laboratory may help scientists create new and better models to learn about cancer and to test new cancer drugs.

Conditions

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Metastatic Malignant Solid Neoplasm

Recurrent Malignant Solid Neoplasm

Study ID

NCT02474160

Start date

May 19, 2015

Status verified date

Mar, 2026

Completion date

May 4, 2026

Anticipated

Primary completion date

May 4, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients older than 2 months of age who are being evaluated, treated, or enrolled in a clinical trial for cancer at participating sites
  • Patients with a histologically or cytologically confirmed diagnosis of cancer
  • Patients without histologically or cytologically confirmed diagnosis of cancer, but for whom approval has been requested and received from the coordinating site study coordinator

  • Requests for coordinating site approval should only be made if the patient's existing work-up at the time of the request demonstrates a combination of two or more of the following indicating the greater likelihood of a cancerous process in the assessment of the treating physician:

  • Radiographic imaging (computed tomography \[CT\], magnetic resonance imaging \[MRI\], etc.)
  • Elevated tumor markers
  • Clinical symptoms
  • Documented risk factors, known genetic changes (mutation, deletion, fusion, etc.), and/or known familial cancer history or syndrome
  • Complete blood count (CBC) w/differential indicative of a probable hematologic malignancy
  • If the patient will be undergoing surgical resection at a later time and will be accessible to approach for study participation at that time, resected material following cancer diagnosis confirmation is preferred
  • Important: Additional medical, genetic and/or demographic work-up should not be obtained solely for determination of eligibility for protocol 9846 by these criteria. Once available, final histology must be confirmed to the coordinating site detailing the cancer diagnosis for patients enrolled based on the above criteria
  • Patients with a newly diagnosed primary and/or metastatic solid tumor or hematologic malignancy for which they have not yet received treatment
  • Patients with a solid tumor or hematologic malignancy that is recurrent, newly metastasized, or progressing while on treatment indicated by:

  • Radiographic evidence of tumor growth, re-growth, and/or new metastases, OR
  • Documentation by the treating physician of clinical disease progression, OR
  • CBC w/differential and/or flow cytometry for hematologic malignancies
  • Patients currently undergoing treatment (adjuvant, neoadjuvant, etc.)

  • Specimen collection should occur as distant in time from the most recent drug administration as possible (e.g., after completion of a treatment cycle and immediately prior to initiation of the next cycle)
  • Specimens should not be collected from patients between doses within a single treatment cycle
  • Confirmation of viable residual malignancy and/or < 90% tumor necrosis, fibrosis, or hemorrhage must be confirmed to the National Cancer Institute (NCI) coordinating site, as indicated in the final post-operative/post-procedure pathology and/or flow cytometry report
  • Patients with ongoing partial response (PR) or stable disease (SD) are eligible

  • Confirmation of viable malignancy and/or < 90% tumor necrosis, fibrosis, or hemorrhage must be confirmed to the NCI coordinating site, as indicated in the final post-operative/post-procedure pathology and/or flow cytometry report
  • Ability to understand and willingness to sign a written informed consent document indicating their willingness to have their tissue or biologic fluid specimens used for research as outlined in this protocol

  • For pediatric patients, ability and willingness to assent to participation, using an explanation that is understandable/age appropriate, as well as receiving parental permission. Signature requirements for pediatric patients can be adjusted based on local guidelines

Exclusion Criteria:

  • Patients with cancer-like syndromes and/or blood disorders such as systemic mastocytosis, Langerhans cell histiocytosis, chronic eosinophilic leukemia/hypereosinophilic syndrome, lymphomatoid granulomatosis, or monoclonal gammopathy of undetermined significance (MGUS)
  • Patients with invasive fungal infections
  • Patients with active and/or uncontrolled bacterial, fungal, or viral infections or who are still recovering from an infection

  • Actively febrile patients with uncertain etiology of febrile episode
  • All antibiotics prescribed for the treatment of a bacterial infection should be completed at least 1 week (7 days) prior to collection

  • Patients with a hematologic malignancy who are treated with an antibiotic, anti-fungal, and/or anti-viral medication for an active infection who then remain on the treatment for prophylaxis following resolution of the infection as assessed by the treating physician are not excluded
  • No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics
  • Patients receiving antibiotics, antifungals, and/or antivirals for prophylaxis are permissible
  • Antibiotics being administered topically at a location distant from the planned tissue collection site or eye drops for a localized infection are permissible
  • Patients with human immunodeficiency virus (HIV), active or chronic hepatitis (i.e., quantifiable hepatitis B virus \[HBV\]-deoxyribonucleic acid \[DNA\] and/or positive hepatitis B surface antigen \[HbsAg\], quantifiable hepatitis C virus \[HCV\]-ribonucleic acid \[RNA\]) or known history of HCV, HBV, or HIV; testing for HBV, HCV, HIV or other infections for eligibility will be performed only if clinically indicated
  • Patients with hepatitis A as indicated by anti-hepatitis A virus (HAV) IgM reactivity

  • Patients that are anti-HAV IgG reactive only are eligible
  • Specimen collections from patients with benign tumors including but not limited to desmoid tumors, carcinoma in situ, or ongoing evidence of complete disease response (CR)

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational (tissue and blood procurement)

Tumor tissue and blood samples are procured during procedures that are required for the patients' clinical management and stored via xenograft (transplant to another species) models or in vitro cell culture for future analysis.

Interventions

Cytology Specimen Collection Procedure

Procurement of tissue and blood samples

Primary outcome measure

  • Procurement of tissue and blood specimens for research purposes [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Locations

Mercy Hospital Fort Smith

Recruiting

Fort Smith, Arkansas, United States, 72903

Contacts

Site Public Contact

800-378-9373

Principal Investigator:

Jay W. Carlson

Augusta University Medical Center

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Site Public Contact

706-721-2388ga_cares@augusta.edu

Principal Investigator:

Sharad A. Ghamande

John H Stroger Jr Hospital of Cook County

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-864-5204

Principal Investigator:

Deimante M. Tamkus

Cancer Care Specialists of Illinois - Decatur

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

Decatur Memorial Hospital

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

SSM Health Good Samaritan

Recruiting

Mount Vernon, Illinois, United States, 62864

Contacts

Site Public Contact

618-899-1894gayla.hall@ssmhealth.com

Principal Investigator:

Jay W. Carlson

Ascension Via Christi Hospitals Wichita

Recruiting

Wichita, Kansas, United States, 67214

Contacts

Site Public Contact

316-291-4774research@viachristi.org

Principal Investigator:

Dennis F. Moore

Cancer Center of Kansas - Wichita

Recruiting

Wichita, Kansas, United States, 67214

Contacts

Site Public Contact

316-291-4774research@viachristi.org

Principal Investigator:

Dennis F. Moore

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Baptist Memorial Hospital and Cancer Center-Oxford

Recruiting

Oxford, Mississippi, United States, 38655

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Raymond U. Osarogiagbon

Freeman Health System

Recruiting

Joplin, Missouri, United States, 64804

Contacts

Site Public Contact

417-347-4030LJCrockett@freemanhealth.com

Principal Investigator:

Jay W. Carlson

Mercy Hospital Joplin

Recruiting

Joplin, Missouri, United States, 64804

Contacts

Site Public Contact

417-556-3074esmeralda.carrillo@mercy.net

Principal Investigator:

Jay W. Carlson

Delbert Day Cancer Institute at PCRMC

Recruiting

Rolla, Missouri, United States, 65401

Contacts

Site Public Contact

573-458-7504research@phelpshealth.org

Principal Investigator:

Jay W. Carlson

Heartland Regional Medical Center

Recruiting

Saint Joseph, Missouri, United States, 64506

Contacts

Site Public Contact

816-271-7937Trisha.England2@mymlc.com

Principal Investigator:

Jay W. Carlson

Mercy Hospital Springfield

Recruiting

Springfield, Missouri, United States, 65804

Contacts

Site Public Contact

417-269-4520

Principal Investigator:

Jay W. Carlson

CoxHealth South Hospital

Recruiting

Springfield, Missouri, United States, 65807

Contacts

Site Public Contact

417-269-4520

Principal Investigator:

Jay W. Carlson

Mercy Hospital South

Recruiting

St Louis, Missouri, United States, 63128

Contacts

Site Public Contact

314-525-6042Danielle.Werle@mercy.net

Principal Investigator:

Jay W. Carlson

Missouri Baptist Medical Center

Recruiting

St Louis, Missouri, United States, 63131

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Mercy Hospital Saint Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Site Public Contact

314-251-7066

Principal Investigator:

Jay W. Carlson

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

Recruiting

New York, New York, United States, 10032

Contacts

Site Public Contact

212-342-5162cancerclinicaltrials@cumc.columbia.edu

Principal Investigator:

Bret Taback

Mercy Hospital Oklahoma City

Recruiting

Oklahoma City, Oklahoma, United States, 73120

Contacts

Site Public Contact

405-752-3402

Principal Investigator:

Jay W. Carlson

Baptist Memorial Hospital and Cancer Center-Memphis

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Raymond U. Osarogiagbon

More Information

Sponsor

National Cancer Institute LAO

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Cancer Institute LAO on 2026-03-05.