NCT02377869

Brief Summary

Recently, a novel assay for detecting heavy/light chain (HLC) ratios has been reported which enables improvement in paraprotein detection and monitoring in multiple myeloma and other plasma-cell dyscrasias. The prognostic and biological role of the HLC assay has as yet not been studied in CLL. Aims of the proposed study:

  1. 1.To quantify and analyze the prognostic significance of HLC ratios in the serum of CLL patients. (In addition to FLC)
  2. 2.To study the different patterns of Immunoglobulin's subclass antibodies in the serum of patients with CLL and compare them to those of to healthy volunteers.
  3. 3.To perform a sub-analysis in patients with CLL who have autoimmune phenomenon (AIHA and ITP)

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
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 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, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

March 4, 2015

Status Verified

February 1, 2015

Enrollment Period

2 years

First QC Date

February 25, 2015

Last Update Submit

February 25, 2015

Conditions

CLL

Outcome Measures

Primary Outcomes (1)

  • 1) To quantify and analyze the prognostic significance of HLC ratios in the serum of CLL patients. (In addition to FLC)

    5 years

Interventions

No intervantionOTHER

Eligibility Criteria

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

Age\>18 years Patients diagnosed with CLL

You may qualify if:

  • New diagnosed patients with CLL (untreated)

You may not qualify if:

  • Not treated with immunoglobulin Not treated with steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion Medical Center

Haifa, Israel, 31048, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 25, 2015

First Posted

March 4, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2020

Last Updated

March 4, 2015

Record last verified: 2015-02

Locations

IL(1)