NeoplasmsNCT00900198
Collection of Tissue Samples for Cancer Research
An observational study of Neoplasms and Lymphomas, run by National Cancer Institute (NCI) at 17 sites in 2 countries.
Trial summary
Background: -Patients who are being evaluated and/or treated at the NIH Clinical Center and adult patients at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens. Read more about this study
- Who is it for?
- Ages 2 months and older
- Conditions the study is for
- Neoplasms, Lymphomas, Multiple Myeloma
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 6 Jul 2006to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who are being evaluated and/or treated at the NIH Clinical Center (pediatric and adult) and adult patients at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens
Who may be able to join
- Patients 18 years of age and older who are being evaluated and/or treated for cancer at the NIH Clinical Center or at participating sites:
- Who have a newly diagnosed malignancy for which they have not yet received treatment, or
- Who have a previously treated malignancy that is now recurrent or currently progressing on treatment indicated by:
- radiographic evidence of tumor growth and/or new metastases, or
- CBC w/differential and/or flow cytometry, or
- documented evidence by the treating physician of signs/symptoms of clinical disease progression, or
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- Who are currently undergoing treatment and for whom disease response has not yet been assessed,
- ---In this circumstance, specimen collection should occur as distant in time from the most recent drug administration as possible such as after completion of a treatment cycle and immediately prior to initiation of the next cycle.
- Patients with ongoing partial response (PR) or stable disease (SD) are eligible.
- For solid tumor diagnoses, confirmation of viable malignancy and/or <90% tumor necrosis, fibrosis, or hemorrhage per the final pathology must be reported to the coordinating site for patients enrolled with ongoing PR or SD at the time of specimen collection.
- For hematologic malignancies, confirmation of viable malignancy must be reported to the coordinating site per the final 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.
- At the NIH Clinical Center ONLY:
- At the PIs discretion, specimens may be collected from patients 18 years of age and older prior to the development of an invasive cancer, who are being evaluated and/or treated for a confirmed familial cancer syndrome such as but not limited to Hereditary Breast and Ovarian Cancer (HBOC), Hereditary Non-polyposis Colorectal Cancer Syndrome or Hereditary Diffuse Gastric Cancer (HDGC) syndrome.
- Specimens, including blood only, can be collected from patients 18 years of age and older who are being evaluated and/or treated for a hematologic malignancy, including Myelodysplastic Syndrome (MDS) and/or MDS Myeloproliferative Neoplasm (MDS-MPN), that meet all other adult eligibility criteria.
- Due to the different characteristics of hematologic malignancies versus solid tumor malignancies, including methodology for assessment of disease response, residual disease, and progression, evaluation of these factors for determination of protocol eligibility should be made utilizing established standards such as hematopathology, flow cytometry, immunohistochemical analysis, etc.
- Patients younger than 18 years of age and older than 2 months with a histologically or cytologically confirmed diagnosis of cancer (solid tumor or hematologic malignancy) who are being treated for cancer at the NIH Clinical Center or participating clinical sites and who will already be undergoing a clinically necessary medical procedure during which tumor tissue will be resected or needle biopsy tissue or bone marrow aspirate collected. Tissue from neonates will not be collected.
- Ability and willingness to assent to participation, utilizing an explanation that is understandable/age appropriate, as well as receiving parental permission.
- At the NIH Clinical Center ONLY
- -At the PI s discretion, clinically indicated tissue collections may occur from patients with pediatric tumors that are generally benign but are known to undergo malignant transformation, e.g., neurofibromatosis, osteochondromas, pheochromocytoma, etc.
Who cannot join
- Note: Testing for bloodborne pathogens or other infections is not required for eligibility assessment and will be performed only if clinically indicated. Exclusion criteria for bloodborne pathogens and/or other infections is based on existing documentation in the medical record or patient report of such diagnosis at the time of eligibility assessment, if testing is not obtained for clinical indications.
- Patients with cancer-like syndromes and/or blood disorders such as but not limited to 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 infections or who are still recovering from an infection:
- All antibiotics, antifungals, or antivirals prescribed for the treatment of an infection should be completed at least 1 week (7 days) prior to collection.
- No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics.
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- Patients receiving antibiotics, antifungals, 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.
- Note: Use of antibiotics for prophylaxis is not an exclusion.
- Patients with Human Immunodeficiency Virus (HIV), active or chronic hepatitis (i.e., quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA) or known history of HCV or HBV.
- Patients with Hepatitis A as indicated by anti-HAV IgM reactivity
- --Note: Patients that are anti-HAV IgG reactive only are not excluded
- Blood only collections from patients with solid tumors or hematologic malignancy demonstrating partial or stable disease response:
- Blood will not be collected from patients whose disease demonstrates ongoing partial response or ongoing stable disease given the poor rate of model generation from such specimens.
- Blood will not be collected from patients between doses within a single treatment cycle.
- 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).
- Note: Testing for bloodborne pathogens or other infections is not required for eligibility assessment and will be performed only if clinically indicated. Exclusion criteria for bloodborne pathogens and/or other infections is based on existing documentation in the medical record or patient report of diagnosis at the time of eligibility assessment, if testing is not obtained for clinical indications.
- Patients with invasive fungal infections
- Patients with active and/or uncontrolled infections or who are still recovering from an infection:
- Actively febrile patients with uncertain etiology of febrile episode
- All antibiotics should be completed at least 1 week (7 days) prior to collection
- No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics
- Note: Use of antibiotics for prophylaxis is not an exclusion.
- Patients with Human Immunodeficiency Virus (HIV), active or chronic hepatitis (i.e., quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA) or known history of HCV or HBV.
- Patients with Hepatitis A as indicated by anti-HAV IgM reactivity
- --Note: Patients that are anti-HAV IgG reactive only are not excluded
- 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) based on imaging.
- Blood only collections from patients with partial or stable disease response:
- Blood will not be collected from patients whose disease demonstrates ongoing partial response or ongoing stable disease given the poor rate of model generation from such specimens.
- Blood will not be collected from patients between doses within a single treatment cycle.
Trial locations and contacts
17 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 2 countries
United States16 sites, 10 recruiting
- Completed
University of Michigan Ann Arbor
Ann Arbor, Michigan, 48109-0624
- Recruiting
Emory University
Atlanta, Georgia, 30322
Kathryn S Sutton, MD, 404-785-1651, kathryn.sutton@choa.org
- Completed
University of Colorado, Denver
Aurora, Colorado, 80220
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21205
Nyall London, M.D. PHD, 801-547-7851, nyall.london@nih.gov
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York
John Kane, MD, 716-845-3284, John.Kane@RoswellPark.org
- Completed
Medical University of South Carolina
Charleston, South Carolina, 29425
- Completed
University of Virginia, Charlottesville
Charlottesville, Virginia, 22903
- Recruiting
Ohio State University
Columbus, Ohio, 43210
Jim Rocco, MD, PhD, 614-685-6778, James.Rocco@osumc.edu
Kyle VanKoevering, MD, (614) 685-6778, kyle.vankoevering@osumc.edu
- Recruiting
Indiana University - Purdue
Indianapolis, Indiana, 46202-5262
Anna Maria Storniolo, MD, 317-948-7576, astornio@iu.edu
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Stephanie Chen, MD, 319-678-8462, stephanie-chen@uiowa.edu
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213-2582
Rakesh Sindhi, MD, 412-692-7849, Rakesh.Sindhi@chp.edu
- Completed
UC Davis
Sacramento, California, 95616
- Completed
University of Utah
Salt Lake City, Utah, 84112
- Recruiting
Fred Hutchinson
Seattle, Washington, 28104
Kelly Smith, MD PhD, 206-598-7143, kelsmith@uw.edu
- Recruiting
Washington University - St. Louis
St Louis, Missouri, 63110
Roheena Panni, MD, 314-362-7046, roheenazpanni@wustl.edu
About this study
Official title: Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)
Background:
-Patients who are being evaluated and/or treated at the NIH Clinical Center and adult patients at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens.
Read more
Objectives:
- To obtain samples from adult and pediatric patients for research purposes from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment.
- To obtain samples for research purposes from non-surgical procedures, such as percutaneous biopsies, performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol.
Eligibility:
-Adult patients (18 years of age and older) and pediatric patients (younger than 18 years of age) who are being evaluated for and/or treated for cancer at the NIH Clinical Center participating sites.
Design:
- This is a multicenter tissue procurement protocol with NCI as the coordinating center.
- For adult patients: specimens for research purposes, as outlined in this protocol, will be obtained from tests and procedures that are done as required by the primary research protocols to which a patient is enrolled or as part of their standard-of-care treatment. Non-surgical procedures, such as percutaneous biopsies, may also be performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Tissues and biological fluids to be procured may include but are not limited to blood, serum, urine, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), circulating tumor cells, hair follicles, and bone marrow. These specimens will be stored with unique identifiers and used to perform only those research studies that are outlined in this protocol.
- For pediatric patients: tumor biopsy/resection tissue used for pediatric preclinical model development will only be from tissue already being obtained as part of a procedure necessary for the patient s clinical care or as part of a primary research protocol; blood specimens will be collected as part of a blood collection already scheduled for the patient s clinical care or as part of the planned pre-procedure bloodwork; volumes collected will not exceed institutional research limits.
- Given the risks associated with any invasive procedure, such as tumor biopsy, the procedure will be discussed in detail with the patients and their parents/guardian (as indicated), including the side effects, prior to obtaining a separate consent for each procedure. A separate consent will not be signed prior to obtaining samples by minimally invasive measures, such as venipuncture.
- This study has two separate consent forms at the NIH Clinical Center: one for adult patients to donate specimens for ongoing research on assay development and studies of molecular pathways, and one for adult and age-appropriate pediatric patients to donate samples for the generation of preclinical models. The study also has consent form templates for adult and pediatric patients at participating sites to donate specimens to create preclinical models.
- Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.
Read the detailed description
Background:
Patients who are being evaluated and/or treated at the NIH Clinical Center and at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens.
Objectives:
To obtain specimens from adult and pediatric patients for research purposes from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment.
To obtain specimens for research purposes from non-surgical procedures, such as percutaneous biopsies, performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol.
Eligibility:
Adult patients (18 years of age and older) and pediatric patients (younger than 18 years of age) who are being evaluated for and/or treated for cancer at the NIH Clinical Center and at participating sites.
Design:
This is a multicenter tissue procurement protocol with NCI as the coordinating center.
For adult patients: specimens for research purposes, as outlined in this protocol, will be obtained from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment. Non-surgical procedures, such as percutaneous biopsies, may also be performed on adult patients at the NIH Clinical Center for the sole purpose of obtaining tissue specimens or biological fluids. Tissues and biological fluids to be procured may include blood, serum, urine, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), circulating tumor cells (CTCs), hair follicles, bone marrow and bone marrow aspirate. These specimens will be stored with unique identifiers and used to perform only those research studies that are outlined in this protocol.
For pediatric patients: tumor biopsy/resection tissue used for pediatric preclinical model development will only be from tissue already being obtained as part of a procedure necessary for the patient s clinical care or as part of a primary research protocol; blood specimens will be collected as part of a blood collection already scheduled for the patient s clinical care or as part of the planned pre-procedure bloodwork; volumes collected will not exceed institutional research limits.
Given the risks associated with any invasive procedure, such as tumor biopsy, the procedure will be discussed in detail with the patients and their parents/guardian (as indicated), including the side effects, prior to obtaining a separate consent for each procedure. A separate consent will not be signed prior to obtaining specimens by minimally invasive measures, such as venipuncture.
This study has two separate consent forms at the NIH Clinical Center: one for adult patients to donate specimens for ongoing research on assay development and studies of molecular pathways; and one for adult and age-appropriate pediatric patients to donate samples for the generation of preclinical models. The study also has consent form templates for adult and pediatric patients at participating sites to donate specimens to create preclinical models.
Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.
- Conditions
- Neoplasms, Lymphomas, Multiple Myeloma, Myelodysplastic Syndrome
- Being tested
- Biopsy
- Keywords
- Tissue Collection, Biospecimen, Assay Development, Tissue Acquisition, Tissue Biopsies, Natural History
- Medical subject headings
- Neoplasms, Lymphoma, Multiple Myeloma, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Tissue samples will be collected for research purposes from non-surgical procedures, such percutaneous biopsies for the sole purpose of obtaining specimens or biological fluids for the protocol.
| Study group | Role | What they receive |
|---|---|---|
| 1/Standard | Standard Receives: Procedure: Biopsy | |
| 2/Standard and Preclinical Models | Standard and Preclinical Models | |
| 3/Preclinical Models | Preclinical Models | |
| 4/Preclinical Models, Pediatric | Preclinical Models, Pediatric |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of research samples
Delinking of patient samples for research
Measured: Day of collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study start6 Jul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- James H Doroshow, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900198
- Sponsor's protocol ID
- 060213
- Other IDs
- 06-C-0213
- Status last verified
- 13 Oct 2026
- First submitted
- 9 May 2009
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)
- ClinicalTrials.gov ID
- NCT00900198
- Acronym / sponsor ID
- 060213
- Conditions
- Neoplasms, Lymphomas, Multiple Myeloma, Myelodysplastic Syndrome
- Keywords
- Tissue Collection, Biospecimen, Assay Development, Tissue Acquisition, Tissue Biopsies, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 6 Jul 2006 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
-Patients who are being evaluated and/or treated at the NIH Clinical Center and adult patients at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens.
Objectives:
- To obtain samples from adult and pediatric patients for research purposes from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment.
- To obtain samples for research purposes from non-surgical procedures, such as percutaneous biopsies, performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol.
Eligibility:
-Adult patients (18 years of age and older) and pediatric patients (younger than 18 years of age) who are being evaluated for and/or treated for cancer at the NIH Clinical Center participating sites.
Design:
- This is a multicenter tissue procurement protocol with NCI as the coordinating center.
- For adult patients: specimens for research purposes, as outlined in this protocol, will be obtained from tests and procedures that are done as required by the primary research protocols to which a patient is enrolled or as part of their standard-of-care treatment. Non-surgical procedures, such as percutaneous biopsies, may also be performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol. Tissues and biological fluids to be procured may include but are not limited to blood, serum, urine, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), circulating tumor cells, hair follicles, and bone marrow. These specimens will be stored with unique identifiers and used to perform only those research studies that are outlined in this protocol.
- For pediatric patients: tumor biopsy/resection tissue used for pediatric preclinical model development will only be from tissue already being obtained as part of a procedure necessary for the patient s clinical care or as part of a primary research protocol; blood specimens will be collected as part of a blood collection already scheduled for the patient s clinical care or as part of the planned pre-procedure bloodwork; volumes collected will not exceed institutional research limits.
- Given the risks associated with any invasive procedure, such as tumor biopsy, the procedure will be discussed in detail with the patients and their parents/guardian (as indicated), including the side effects, prior to obtaining a separate consent for each procedure. A separate consent will not be signed prior to obtaining samples by minimally invasive measures, such as venipuncture.
- This study has two separate consent forms at the NIH Clinical Center: one for adult patients to donate specimens for ongoing research on assay development and studies of molecular pathways, and one for adult and age-appropriate pediatric patients to donate samples for the generation of preclinical models. The study also has consent form templates for adult and pediatric patients at participating sites to donate specimens to create preclinical models.
- Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.
Detailed description
Background:
Patients who are being evaluated and/or treated at the NIH Clinical Center and at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens.
Objectives:
To obtain specimens from adult and pediatric patients for research purposes from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment.
To obtain specimens for research purposes from non-surgical procedures, such as percutaneous biopsies, performed for the sole purpose of obtaining tissue specimens or biological fluids for this protocol.
Eligibility:
Adult patients (18 years of age and older) and pediatric patients (younger than 18 years of age) who are being evaluated for and/or treated for cancer at the NIH Clinical Center and at participating sites.
Design:
This is a multicenter tissue procurement protocol with NCI as the coordinating center.
For adult patients: specimens for research purposes, as outlined in this protocol, will be obtained from tests and procedures that are done as required by the primary research protocol(s) to which a patient is enrolled or as part of their standard-of-care treatment. Non-surgical procedures, such as percutaneous biopsies, may also be performed on adult patients at the NIH Clinical Center for the sole purpose of obtaining tissue specimens or biological fluids. Tissues and biological fluids to be procured may include blood, serum, urine, tumor tissue, normal tissue, pleural fluid, CSF, saliva, bronchial alveolar lavage (BAL), circulating tumor cells (CTCs), hair follicles, bone marrow and bone marrow aspirate. These specimens will be stored with unique identifiers and used to perform only those research studies that are outlined in this protocol.
For pediatric patients: tumor biopsy/resection tissue used for pediatric preclinical model development will only be from tissue already being obtained as part of a procedure necessary for the patient s clinical care or as part of a primary research protocol; blood specimens will be collected as part of a blood collection already scheduled for the patient s clinical care or as part of the planned pre-procedure bloodwork; volumes collected will not exceed institutional research limits.
Given the risks associated with any invasive procedure, such as tumor biopsy, the procedure will be discussed in detail with the patients and their parents/guardian (as indicated), including the side effects, prior to obtaining a separate consent for each procedure. A separate consent will not be signed prior to obtaining specimens by minimally invasive measures, such as venipuncture.
This study has two separate consent forms at the NIH Clinical Center: one for adult patients to donate specimens for ongoing research on assay development and studies of molecular pathways; and one for adult and age-appropriate pediatric patients to donate samples for the generation of preclinical models. The study also has consent form templates for adult and pediatric patients at participating sites to donate specimens to create preclinical models.
Patients may remain on study for the duration of their consent or completion of the planned procedure, whichever comes first.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1/Standard | – | Procedure: BiopsyStandard |
| 2/Standard and Preclinical Models | – | –Standard and Preclinical Models |
| 3/Preclinical Models | – | –Preclinical Models |
| 4/Preclinical Models, Pediatric | – | –Preclinical Models, Pediatric |
Who may qualify
- Ages
- 2 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are being evaluated and/or treated at the NIH Clinical Center (pediatric and adult) and adult patients at participating sites will be entered onto this tissue procurement protocol for collection of tissue specimens
Key inclusion criteria (20 listed)
- Patients 18 years of age and older who are being evaluated and/or treated for cancer at the NIH Clinical Center or at participating sites:
- ---In this circumstance, specimen collection should occur as distant in time from the most recent drug administration as possible such as after completion of a treatment cycle and immediately prior to initiation of the next cycle.
- 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.
- At the PIs discretion, specimens may be collected from patients 18 years of age and older prior to the development of an invasive cancer, who are being evaluated and/or treated for a confirmed familial cancer syndrome such as but not limited to Hereditary Breast and Ovarian Cancer (HBOC), Hereditary Non-polyposis Colorectal Cancer Syndrome or Hereditary Diffuse Gastric Cancer (HDGC) syndrome.
- Specimens, including blood only, can be collected from patients 18 years of age and older who are being evaluated and/or treated for a hematologic malignancy, including Myelodysplastic Syndrome (MDS) and/or MDS Myeloproliferative Neoplasm (MDS-MPN), that meet all other adult eligibility criteria.
Key exclusion criteria (30 listed)
- Note: Testing for bloodborne pathogens or other infections is not required for eligibility assessment and will be performed only if clinically indicated. Exclusion criteria for bloodborne pathogens and/or other infections is based on existing documentation in the medical record or patient report of such diagnosis at the time of eligibility assessment, if testing is not obtained for clinical indications.
- Patients with cancer-like syndromes and/or blood disorders such as but not limited to 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 infections or who are still recovering from an infection:
- Patients with Human Immunodeficiency Virus (HIV), active or chronic hepatitis (i.e., quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA) or known history of HCV or HBV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyTissue samples will be collected for research purposes from non-surgical procedures, such percutaneous biopsies for the sole purpose of obtaining specimens or biological fluids for the protocol. | Procedure or surgery | 1/Standard |
Primary outcome
Collection of research samples
Time frame: Day of collection
Delinking of patient samples for research
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James H Doroshow, M.D. principal investigator
National Cancer Institute (NCI)
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms and Lymphomas, run by National Cancer Institute (NCI) at 17 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy A Moore, R.N. ((240) 760-6045, nancy.moore@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of research samples (time frame: Day of collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.