NCT01827514

Brief Summary

Erythropoietin, EPO, is the main regulator and stimulator of bone marrow erythropoiesis, and is responsible for growth and differentiation of the erythroid cell lineage. Our team, in collaboration with partners (see below) has taken responsibility to study the presence, function and clinical significance of EPO-R in human cancer specimens. General Aim of the Proposed Project: To study EPO-R in human cancer specimens. Prepared slides from already taken preparations (specimens from Bone Marrow tests) will serve as the basis for that part of the work.Specimens will be taken from Breast cancer, Colon cancer, Lung cancer, Head \& Neck cancer and from Lymph nodes biopsy (positive for lymphoma) The slides will be stained with anti-EPO-R antibodies (Abs).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 9, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 9, 2013

Status Verified

April 1, 2013

Enrollment Period

2 years

First QC Date

March 13, 2013

Last Update Submit

April 4, 2013

Conditions

Cancer

Keywords

cancer, erythropoetin

Outcome Measures

Primary Outcomes (1)

  • anti-EPO-R antibodies staining

    The specimens from Biopsy/Bone Marrow test will be collected once immediately after ICF signing in prospective part. In retrospective part, the specimens will be taken once from the same donor.

    1 year

Secondary Outcomes (1)

  • Follow up after prospective participants

    3 years

Study Arms (1)

People with diagnosed cancer

People wich were diagnosed with one of specific type of cancer: breast, lung, colon, head, neck and lymphoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with one of listed above types of cancer.

You may qualify if:

  • Adult (more than 17 years old)
  • With one of next cancer types: breast, lung, colon, head, neck and lymphoma
  • I prospective part only: that signed ICF

You may not qualify if:

  • Teenagers below 18 years old
  • In prospective part: that did not sign ICF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Related Publications (5)

  • Lin FK, Suggs S, Lin CH, Browne JK, Smalling R, Egrie JC, Chen KK, Fox GM, Martin F, Stabinsky Z, et al. Cloning and expression of the human erythropoietin gene. Proc Natl Acad Sci U S A. 1985 Nov;82(22):7580-4. doi: 10.1073/pnas.82.22.7580.

    PMID: 3865178BACKGROUND

  • Eschbach JW, Kelly MR, Haley NR, Abels RI, Adamson JW. Treatment of the anemia of progressive renal failure with recombinant human erythropoietin. N Engl J Med. 1989 Jul 20;321(3):158-63. doi: 10.1056/NEJM198907203210305.

    PMID: 2747747BACKGROUND

  • Spivak JL. Recombinant human erythropoietin and the anemia of cancer. Blood. 1994 Aug 15;84(4):997-1004. No abstract available.

    PMID: 8049455BACKGROUND

  • Bokemeyer C, Aapro MS, Courdi A, Foubert J, Link H, Osterborg A, Repetto L, Soubeyran P; European Organisation for Research and Treatment of Cancer (EORTC) Taskforce for the Elderly. EORTC guidelines for the use of erythropoietic proteins in anaemic patients with cancer: 2006 update. Eur J Cancer. 2007 Jan;43(2):258-70. doi: 10.1016/j.ejca.2006.10.014. Epub 2006 Dec 19.

    PMID: 17182241BACKGROUND

  • Rizzo JD, Somerfield MR, Hagerty KL, Seidenfeld J, Bohlius J, Bennett CL, Cella DF, Djulbegovic B, Goode MJ, Jakubowski AA, Rarick MU, Regan DH, Lichtin AE. Use of epoetin and darbepoetin in patients with cancer: 2007 American Society of Hematology/American Society of Clinical Oncology clinical practice guideline update. Blood. 2008 Jan 1;111(1):25-41. doi: 10.1182/blood-2007-08-109488. Epub 2007 Oct 22.

    PMID: 17954703BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Retrospective part: prepared slides from already taken preparations (specimens from Biopsy/Bone Marrow tests) will serve as the basis for that part of the work - samples without available DNA. Prospective part: fresh material samples will be taken from biopsies in the operating room from Biopsy/Bone Marrow tests and will be used to prapare the slides for the study tests. There is an available DNA before slide staining.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Moshe Mittelman, Prof.

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Manager of Research and Development department

Study Record Dates

First Submitted

March 13, 2013

First Posted

April 9, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2016

Last Updated

April 9, 2013

Record last verified: 2013-04

Locations

IL(1)