Clinical trial NCT00898235: Collection of Samples and Clinical Data From Patients With Amyloid Diseases
Official title: Data, Tissue, Blood, and Urine Repository for Amyloid Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Keywords: primary systemic amyloidosis
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2009-05-12
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants diagnosed, or with suspicion of having, amyloidosis

Brief summary: RATIONALE: Collecting and storing samples of blood, urine, tissue and data from patients with amyloid diseases to test in the laboratory may help the study of this disease in the future.

PURPOSE: This research study is collecting samples from patients with amyloid diseases

Detailed description: OBJECTIVES:

* To establish and maintain a database of clinical material (i.e., blood, urine, and tissue) and information on patients with amyloid diseases.

OUTLINE: Blood, urine, tissue, and bone marrow samples are collected during standard laboratory evaluations to maintain a repository of biospecimens in the Gerry Amyloid Research Laboratory, to permit the correlation of clinical results with measured biological events, and for future research studies. Bone marrow RNA samples are examined for immunoglobulin light-chain gene sequences and amino acids by polymerase chain reaction and positional cloning. Blood serum and urine samples are evaluated for amyloid protein stability by high-resolution calorimetry, isothermal-titration calorimetry, and far- and near-UV circular dichroism and fluorescence spectroscopy. Urine samples are also examined for post-translational modifications (e.g., glycosylation, sulfation, and cross-linking) to identify common features unique to amyloid proteins. Tissue samples are analyzed for biochemical and biophysical properties and for post-translational modifications in light chains.

Quality of life is assessed by the 36-Item Short Form Survey (SF-36).

Eligibility criteria: Inclusion Criteria:

DISEASE CHARACTERISTICS:

* Diagnosis or suspicion of amyloidosis

PATIENT CHARACTERISTICS:

* Referred to the Amyloid Treatment and Research Center at Boston University Medical Center

PRIOR CONCURRENT THERAPY:

* Not specified

Exclusion Criteria:

None

Primary outcomes:
measure: Establish a repository to promote biochemical research
timeFrame: life of study
Secondary outcomes:
measure: Collection of clinical material and information
timeFrame: life of study
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Cancer Research Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Vaishali Sanchorawala, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Staron A, Burks EJ, Lee JC, Sarosiek S, Sloan JM, Sanchorawala V. Assessment of minimal residual disease using multiparametric flow cytometry in patients with AL amyloidosis. Blood Adv. 2020 Mar 10;4(5):880-884. doi: 10.1182/bloodadvances.2019001331.
citation: Staron A, Connors LH, Ruberg FL, Mendelson LM, Sanchorawala V. A new era of amyloidosis: the trends at a major US referral centre. Amyloid. 2019 Dec;26(4):192-196. doi: 10.1080/13506129.2019.1640672. Epub 2019 Jul 15.
citation: Lilleness B, Ruberg FL, Mussinelli R, Doros G, Sanchorawala V. Development and validation of a survival staging system incorporating BNP in patients with light chain amyloidosis. Blood. 2019 Jan 17;133(3):215-223. doi: 10.1182/blood-2018-06-858951. Epub 2018 Oct 17.
citation: Shu J, Lo S, Phillips M, Sun F, Seldin DC, Berenbaum I, Berk JL, Sanchorawala V. Depression and anxiety in patients with AL amyloidosis as assessed by the SF-36 questionnaire: experience in 1226 patients. Amyloid. 2016 Sep;23(3):188-193. doi: 10.1080/13506129.2016.1208081. Epub 2016 Jul 27.
citation: Cowan AJ, Skinner M, Seldin DC, Berk JL, Lichtenstein DR, O'Hara CJ, Doros G, Sanchorawala V. Amyloidosis of the gastrointestinal tract: a 13-year, single-center, referral experience. Haematologica. 2013 Jan;98(1):141-6. doi: 10.3324/haematol.2012.068155. Epub 2012 Jun 24.