ClinicalTrials.gov record NCT00898235
Collection of Samples and Clinical Data From Patients With Amyloid Diseases
Data, Tissue, Blood, and Urine Repository for Amyloid Diseases
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This prospective registry collects and stores blood, urine, tissue, and clinical information from people with amyloid diseases or suspected amyloidosis (the record also lists multiple myeloma). Samples are taken during standard laboratory evaluations and used for genetic and protein analyses. Quality of life is measured with the SF-36 at follow-up visits; the repository is kept for future biochemical research.
What it is studying. The study is building a repository of biospecimens and linked clinical information so researchers can study the biochemical and genetic features of amyloid proteins and relate those features to clinical data and quality-of-life measures.
What the researchers hope to learn. Create and maintain a biorepository and database to support biochemical and genetic research on amyloid proteins (for example, light-chain gene sequencing, protein stability and post‑translational modification studies) and to collect quality-of-life information.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Genetic
- clonality analysis
- polymerase chain reaction
- protein analysis
- Procedure
- fluorescence spectroscopy
- quality-of-life assessment
- Other
- biologic sample preservation procedure
- laboratory biomarker analysis
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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).
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Provide blood and urine samples and, when part of standard clinical care, tissue and bone marrow samples that will be stored in a research repository. Samples are used for genetic and protein/biomarker analyses and related laboratory research. Complete the 36-Item Short Form Survey (SF-36) about quality of life at follow-up visits, with follow-up assessments described for the life of the study. The registry record does not specify how often visits occur or other participant services.
How the study is structured. A prospective observational registry: researchers collect and store blood, urine, tissue, and clinical data over time. No experimental treatment is assigned; laboratory analyses and a quality-of-life survey (SF-36) are performed on collected specimens and data.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on AL amyloidosis
Important dates
- Study start
- January 2000
- Primary completion
- December 2040 (estimated)
- Study completion
- December 2040 (estimated)
- Target enrollment
- 10000 participants (estimated)
- Last updated on registry
- Dec 1, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Boston Medical Center
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Vaishali Sanchorawala, MD 📞 617-638-8261 ✉ vaishali.sanchorawala@bmc.org
- Annie Jose, BS 📞 617 638 8213 ✉ annie.jose@bmc.org
Participating sites (1)
- Boston University Cancer Research CenterRecruiting
Boston, Massachusetts, 02118 · United States
- Clinical Trials Office - Boston University Cancer Research Cen · 617-638-8265
Terms used on this page · explanations by MedicalUpdates.ai
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- biospecimens
- A collection of biological samples, such as blood or tissue, stored with medical information so that researchers can study them later.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
← Back to clinical trials