ClinicalTrials.gg
RecruitingNCT02682667Updated Nov 9, 2026

Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols

An observational study in Multiple Myeloma, Lymphoma, Non-Hodgkin and Leukemia-Lymphoma, Adult T-Cell, sponsored by National Cancer Institute (NCI). Recruiting at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by National Cancer Institute (NCI) · Observational

From the registry’s dates

  • Started Apr 2016; still recruiting 10 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 120 Years
Sex
All
01

Study summary

Background:

Cancer has a major impact in the United States and across the world. In 2015, over 1.5 million new cases of cancer were diagnosed in the U.S. Researchers want to study samples from people with cancer or a pre-malignant condition. They hope to develop more effective treatments.

Objective:

To better understand the biology of malignancies and why certain cancers respond differently to treatment.

Eligibility:

Adults at least 18 years old with cancer or a pre-cancerous condition.

Design:

Participants will be screened with a medical history, physical exam, and blood tests. Their diagnosis will be confirmed by the NCI Laboratory of Pathology.

Participants will send tissue blocks or slides from their original tumor biopsy.

At least once, participants will have a medical history, physical exam, and blood and urine tests.

Participants may have the following tests. They may have them more than once:

Apheresis. A needle in one arm removes blood. Blood is run through a machine and the sample cells are taken out. The rest of the blood is returned by a needle in the other arm.

Bone marrow aspiration and biopsy. The hipbone will be numbed. A needle will be put into the hipbone. Bone marrow will be taken out through the needle.

Piece of cancer tissue taken by a needle and syringe.

Computed tomography (CT) scan, magnetic resonance imaging (MRI) and/or positron emission tomography (PET) scan or ultrasound to help locate their tumor. For the scans, they lie in a machine that takes pictures.

A small piece of skin removed.

Participants will be contacted by phone once a year to find out how they are doing.

Read the detailed description

Background:

-Immunotherapy is a promising approach to the treatment of cancer. CIO investigators are studying immunotherapy for the treatment of diverse malignant and premalignant conditions. These studies require the collection of biospecimens for research purposes.

Objectives:

  • To collect and bank blood, apheresis products, tumor, body fluids, and other biospecimens from patients with cancer or a premalignant disease or at risk of cancer from an immunodeficiency.
  • To collect and bank biospecimens as directed by companion CIO immunotherapy clinical trial protocols.
  • To conduct nucleic acid, protein, and immunological and biological research studies on samples collected.

Eligibility:

-Patients must be 18 years of age or older with a diagnosis of cancer or a premalignant condition or an immunodeficiency that increases the risk of being diagnosed with a cancer or premalignant condition.

Design:

  • Up to 500 subjects will be enrolled.
  • Patients will undergo sampling of blood, apheresis products, tumor, effusions, ascites, urine, bone marrow, serum, plasma, skin, mucosa, or other tissues for banking and laboratory studies.
  • No investigational or experimental therapy will be given as part of this protocol.
  • Re-enrollment will be allowed for a small number of participants.
02

Conditions studied

  • Multiple Myeloma
  • Lymphoma, Non-Hodgkin
  • Leukemia-Lymphoma, Adult T-Cell
  • Hodgkin Disease
  • Non-Small Cell Lung Cancer

Keywords

  • Apheresis Products
  • Immunological
  • Diverse Malignan
  • Premalignant
  • Protein
  • Natural History
03

In context

Multiple Myeloma

3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.

This study's planned enrollment of 500 is above the median of 150 across 486 observational studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.

Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants will be any person over the age of 18 with a diagnosis of cancer or a premalignant disease. Participants are selected from other NIH protocols (including screening protocols) they may be co-enrolled on and can include both inpatient and outpatient.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Diagnosis of cancer, a premalignant/neoplastic condition or disease (such as an immunodeficiency) that increases the risk of being diagnosed with a cancer or premalignant/neoplastic condition

    1. Age >=18 years of age
    2. performance status of 0-3.

    5. Ability and willingness of subject to provide

Additional inclusion criteria pertinent only for participants undergoing apheresis

  1. >= 8 mg/dL and count > 75 K/microL
  2. Weight >= 48 kg
  3. Central line in place or adequate venous access

Exclusion criteria

EXCLUSION CRITERIA:

  1. Active concomitant medical or psychological illnesses that may increase the risk to the subject.
  2. Inability to provide
  3. Pregnant or breastfeeding women
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)

Groups and cohorts

  • 1/Cohort 1

    Patients with cancer or a premalignant condition or at risk of cancer from an immunodeficiency

06

What researchers measure

Primary outcomes

  1. Sample Acquisition

    Biospecimen collection for study and understanding of disease.

    Time frame: Ongoing

Secondary outcomes

  1. Associations between clinical parameters, biospecimen characteristics and patient demographics

    Correlation of these characteristics with disease.

    Time frame: Ongoing

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Clinical data available during the study and indefinitely.@@@@@@@@@@@@Genomic data will be shared from the time of upload to dbGaP.

Access criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.@@@@@@@@@@@@Genomic IPD will be shared through dbGaP, per rules of the database, for purposes of genomic analysis.

09

Updates

5 registry updates since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: description and verification date
5 updates, last Nov 9, 2026
Show all 5 updates
  1. Nov 9, 2026
    Minor edits only
    + 1 other change: description
  2. Nov 5, 2026
    Minor edits only
    + 1 other change: description
  3. Oct 26, 2026
    Minor edits only
    + 1 other change: description
  4. Oct 16, 2026
    Minor edits only
    + 2 other changes: verification date and description
  5. Sep 28, 2026
    Minor edits only
    + 1 other change: description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT02682667
Responsible party
Sponsor
First posted
Feb 15, 2016
Start date
Apr 11, 2016
Primary completion
Dec 1, 2030 (estimated)
Completion
Dec 1, 2032 (estimated)
Last update
Nov 9, 2026

Study contacts

Scott M Norberg, D.O.
Contact
scott.norberg@nih.gov
(301) 275-9668
Scott M Norberg, D.O.
principal investigator · National Cancer Institute (NCI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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