Collection of Tissue Samples for Cancer Research

• ClinicalTrials.gov Identifier: NCT00900198
• Recruitment Status: Recruiting
• First Posted: May 12, 2009
• Last Update Posted: February 8, 2023
• Sponsor: National Cancer Institute (NCI)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Tracking Information

• First Submitted Date: May 9, 2009
• First Posted Date: May 12, 2009
• Last Update Posted Date: February 8, 2023
• Actual Study Start Date: July 6, 2006
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: January 13, 2022)

Collection of research samples [ Time Frame: Day of collection ]

Delinking of patient samples for research

• Original Primary Outcome Measures (submitted: May 9, 2009): Tissue and fluid collection
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Collection of Tissue Samples for Cancer Research
• Official Title: Tissue Procurement Protocol for the Developmental Therapeutics Clinic, National Cancer Institute (NCI)

Brief 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.

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 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 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, 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 samples 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 samples 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 Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Other
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• 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

Condition

• Neoplasms
• Lymphomas
• Multiple Myeloma
• Myelodysplastic Syndrome

Intervention

Procedure: Biopsy

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 Groups/Cohorts

• 1/Standard
  Standard
  Intervention: Procedure: Biopsy
• 2/Standard and Preclinical Models
  Standard and Preclinical Models
• 3/Preclinical Models
  Preclinical Models
• 4/Preclinical Models, Pediatric
  Preclinical Models, Pediatric

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 21, 2020): 5000
• Original Estimated Enrollment (submitted: May 9, 2009): 100
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility Criteria

• INCLUSION CRITERIA - ADULT:

• 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

  • documented evidence by the treating physician of signs/symptoms of clinical disease progression, or

    --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.

  • Confirmation of viable malignancy and/or <90% tumor necrosis per the final pathology report must be confirmed to the coordinating site for patients enrolled with ongoing PR or SD at the time of specimen collection.
• 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 participating sites, eligible malignancy for enrollment is limited to solid tumors, lymphoma, and Multiple Myeloma (MM).

-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 Nonpolyposis 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.

EXCLUSION CRITERIA - ADULT:

• 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. Testing for hepatitis B or other infections for eligibility will be performed only if clinically indicated.

• 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, lymphoma or multiple myeloma 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).

INCLUSION CRITERIA - PEDIATRIC:

• Patients younger than 18 years of age and older than 2 months with a histologically or cytologically confirmed diagnosis of cancer (solid tumor, lymphoma or multiple myeloma) 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 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.

EXCLUSION CRITERIA - PEDIATRIC:

• 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. Testing for hepatitis B or other infections for eligibility will be performed only if clinically indicated.

• 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 samples.
  • Blood will not be collected from patients between doses within a single treatment cycle.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Nancy Moore, R.N.; (240) 760-6045; nancy.moore@nih.gov

Contact: James H Doroshow, M.D.; (240) 781-3320; doroshoj@mail.nih.gov

• Listed Location Countries: United States
• Removed Location Countries: Canada

Administrative Information

• NCT Number: NCT00900198
• Other Study ID Numbers: 060213; 06-C-0213
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
• Original Responsible Party: Not Provided
• Current Study Sponsor: National Cancer Institute (NCI)
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: James H Doroshow, M.D.; National Cancer Institute (NCI)

• PRS Account: National Institutes of Health Clinical Center (CC)
• Verification Date: February 3, 2023