Collection of Samples and Clinical Data From Patients With Amyloid Diseases

NCT00898235 | Recruiting

• 2 other identifiers: H-22838CDR0000632869
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Myeloma

Keywords

primary systemic amyloidosis

Outcome Measures

Primary Outcomes (1)

• Establish a repository to promote biochemical research

  life of study

Secondary Outcomes (1)

• Collection of clinical material and information

  life of study

Interventions

clonality analysis GENETIC

analyze clonality

polymerase chain reaction GENETIC

analyze polymerase chain reaction

protein analysis GENETIC

analyze protein

biologic sample preservation procedure OTHER

preserve biologic samples

laboratory biomarker analysis OTHER

analyze laboratory biomarkers

fluorescence spectroscopy PROCEDURE

perform fluorescence spectroscopy on specimens

quality-of-life assessment PROCEDURE

assess quality of life at each follow-up for life

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants diagnosed, or with suspicion of having, amyloidosis

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston University Cancer Research Center

Boston, Massachusetts, 02118, United States

RECRUITING

Related Publications (6)

• Ramireddy S, Prokaeva T, Chen H, Spencer B, Wong S, Dasari S, Dao L, McPhail ED, Sanchorawala V, Mendelson L. The Amyloidosis Intersection: Dual Amyloid Types in a Single Host. Eur J Haematol. 2025 Sep;115(3):287-298. doi: 10.1111/ejh.14429. Epub 2025 Jun 17.

  PMID: 40526008 DERIVED

• 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.

  PMID: 32130406 DERIVED

• 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.

  PMID: 31306033 DERIVED

• 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.

  PMID: 30333122 DERIVED

• 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.

  PMID: 27460276 DERIVED

• 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.

  PMID: 22733017 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood, urine, and tissue

MeSH Terms

Conditions

Multiple Myeloma; Immunoglobulin Light-chain Amyloidosis

Interventions

Polymerase Chain Reaction; Spectrometry, Fluorescence

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Spectrum Analysis

Study Officials

• Vaishali Sanchorawala, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vaishali Sanchorawala, MD

CONTACT

617-638-8261; vaishali.sanchorawala@bmc.org

Annie Jose, BS

CONTACT

617 638 8213; annie.jose@bmc.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: January 1, 2000
• Primary Completion (Estimated): December 1, 2040
• Study Completion (Estimated): December 1, 2040
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

US (1)