ClinicalTrials.gg
CompletedNCT00900055Updated Jul 5, 2022

Research Study in Healthy Volunteers of Patients With Fanconi Anemia, Myeloproliferative Disorders, or Myeloma

An observational study in Chronic Myeloproliferative Disorders, Fanconi Anemia and Multiple Myeloma and Plasma Cell Neoplasm, sponsored by OHSU Knight Cancer Institute. Completed at 1 site in United States. Open to participants aged 1 Year to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-05.

Sponsored by OHSU Knight Cancer Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
213
Ages
1 Year to 55 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 10 studies in Myeloproliferative Disorders by OHSU Knight Cancer Institute — 1 open to participants now, 1 under way, none of them phase 3. Myeloproliferative Disorders · OHSU Knight Cancer Institute.

Started
1975
the only one that year
Observational
3 of 10
1 open now
Registered
7th of 10
by date

Among the 10 studies in Myeloproliferative Disorders by OHSU Knight Cancer Institute, this one is the only one that started in 1975, is one of 3 observational ones, and was the 7th registered.

Myeloproliferative Disorders

668 studies on the registry are indexed under Myeloproliferative Disorders; 111 are open to participants now.

Browse Myeloproliferative Disorders studies →

Open to participants now

1 of the 10 studies in Myeloproliferative Disorders by OHSU Knight Cancer Institute is open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

Where they have run

Who these studies take

Of the 88 Myeloproliferative Disorders studies recruiting now, 64 (73%) set no upper age limit and 18 (20%) stop at 75 or younger; 22 take children under 18; 6 take healthy volunteers.

This study: 1 Year to 55 Years · all sexes · healthy volunteers too.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Myeloproliferative Disorders by OHSU Knight Cancer Institute, or all of them as a file.
02

Study summary

RATIONALE: Analyzing tissue and blood samples from healthy volunteers or patients with Fanconi anemia, myelodysplasia, myeloproliferative disorders, or myeloma in the laboratory may help doctors learn more about the causes of blood cancers.

PURPOSE: The purpose of this study is to analyze in the laboratory blood and bone marrow cells from healthy volunteers or patients with Fanconi anemia, myeloproliferative disorders, or myeloma.

Read the detailed description

OBJECTIVES:

  • Identify the specific molecular function of the Fanconi anemia (FA) complementing gene products in hematopoietic progenitor cells from patients and normal volunteers.
  • Identify functional defects in hematopoietic stromal cells, including macrophages, from patients with FA, and selected blood cancers as well as normal volunteers.

OUTLINE: Peripheral blood mononuclear leukocytes, skin fibroblasts, and marrow fibroblasts are collected for loss-of-function and gain-of-function analysis related to the Fanconi anemia complementing gene.

03

Conditions studied

  • Chronic Myeloproliferative Disorders
  • Fanconi Anemia
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic/Myeloproliferative Neoplasms

Keywords

  • Fanconi anemia
  • multiple myeloma and other plasma cell neoplasms
  • chronic myeloproliferative disorders
  • myelodysplastic/myeloproliferative neoplasms
04

Who can participate

Ages eligible
1 Year to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The Center for Hematologic Malignancies, the Knight Cancer Institute at OHSU, and the Bone Marrow Failure clinic at Doernbecher Children's Hospital at OHSU will be centers for recruitment.

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Diagnosis of one of the following:

      • Fanconi's anemia requiring bone marrow as part of standard care (adults and children)
      • Myeloproliferative disorder or myeloma (adults)
    • Healthy volunteer, meeting 1 of the following criteria:

      • Over 18 years of age
      • Bone marrow transplant donor (children)

PATIENT CHARACTERISTICS:

  • > 13 g/dL
  • White blood cells (WBC) > 4,000/mm³
  • count > 150,000/mm³
  • No clinical signs or symptoms of acute or subacute infections (viral, bacterial, or fungal)
  • No known blood abnormality (healthy volunteers)
  • No allergies to lidocaine or xylocaine

PRIOR CONCURRENT THERAPY:

  • Not specified
Terms in these criteria, in plain language(3)

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.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

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
213 participants (actual)

Interventions

  • Geneticmicroarray analysis
  • Geneticpolyacrylamide gel electrophoresis
  • Geneticpolymerase chain reaction
  • Geneticprotein expression analysis
  • Geneticreverse transcriptase-polymerase chain reaction
  • Geneticwestern blotting
  • Otherchromatography
  • Otherhigh performance liquid chromatography
  • Otherimmunoenzyme technique
06

What researchers measure

Primary outcomes

  1. Loss of function analyses

    Time frame: Duration of the study

  2. Proteins binding to Fanconi anemia, complementation group C (FACC) gene-product by affinity chromatography of nuclear and whole cell lysates of normal cells

    Time frame: Duration of the study

  3. Screening of proteins binding to FACC gene-product using monoclonal antibodies specific to signal transduction and cell cycle proteins

    Time frame: Duration of the study

  4. Microsequencing of unique proteins

    Time frame: Duration of the study

  5. Location of specific downstream block point imposed by antisense molecules using antibodies specific to signal transduction, cell cycle, or repair proteins for the FACC protein

    Time frame: Duration of the study

  6. Affirmation that the block points identified are recapitulated in progenitor cells from peripheral blood

    Time frame: Duration of the study

  7. Identification of functional defects in Fanconi anemia hematopoietic stromal cells

    Time frame: Duration of the study

07

Study locations

1 site
  • Knight Cancer Institute at Oregon Health and Science University
    Portland, Oregon 97239-3098, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 1975, a primary completion of Aug 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 9, 2009
First posted
May 12, 2009
Start
Jun 1975
Primary completionActual
Aug 23, 2016
CompletionActual
Aug 23, 2016
Last update
Jul 5, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00900055
Responsible party
Laura Newell (Assistant Professor, OHSU Knight Cancer Institute) — Principal investigator
First posted
May 12, 2009
Start date
Jun 1975
Primary completion
Aug 23, 2016
Completion
Aug 23, 2016
Last update
Jul 5, 2022

Study contacts

Laura Newell, MD
principal investigator · OHSU Knight Cancer Institute
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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