NEALS AND NCRI SAMPLE REPOSITORY REQUEST NAME

CORRELACIÓ I REGRESSIÓ LINEALS PER COMENÇAR AQUESTES ACTIVITATS
NEALS AND NCRI SAMPLE REPOSITORY REQUEST NAME

NEALS AND NCRI SAMPLE REPOSITORY REQUEST NAME

NEALS and NCRI SAMPLE REPOSITORY REQUEST

Name:  

Position:  

Institution:  

Shipping Address:  

 

 

 

Telephone:   Fax:   Email:  

Statement: The review process is confidential.

What samples would you like? Please see the Request Form Instructions & Descriptions.

Check all that apply.

Plasma Serum Cerebrospinal Fluid (CSF)

Extracted DNA Whole Blood Urine

Please specify the minimum volume of sample needed per subject. Please note that you are asked to provide a volume justification for the volume(s) indicated below in the Experimental Plan.

  Plasma (P)   Serum (S)   Cerebrospinal Fluid (CSF)

  Extracted DNA   Whole Blood (WB)   Urine (U)

Please specify the type and number of samples needed.

  ALS Subjects   Healthy Subjects   Disease Control Subjects

Is there a specific study that you would like the samples from? Yes No

NEALS Studies. If there is a specific study that you wish to request samples from, please check all that apply. Descriptions of these studies are found in separate document.

A Clinical Trial of Topiramate in ALS (1999-201): Placebo controlled study on 296 study on 296 ALS subjects; P available.

A Clinical Trial of Celebrex in Subjects with ALS (2001-2004): Placebo controlled study on 300 ALS subjects: CSF (Baseline samples no longer available) and S available.

A Clinical Trial of Coenzyme Q10 in Patients with Amyotrophic Lateral Sclerosis (2003-2004): Open label, dose escalation study in 31 ALS subjects; P available.

A Multicenter, Dose-Ranging, Safety & Pharmacokinetics Study of Arimoclomol in ALS – Phase IIa. (2005-2007); Placebo controlled study in 84 ALS subjects; S available.

A Multicenter Study for the Validation of ALS Biomarkers (BIO-01 2008-2011); Observational study of ALS, healthy controls and non-ALS neurological controls (448 subjects, total). CSF, P and S samples available.

A Multicenter Study for the Validation of ALS Biomarkers (BIO-02/LABB 2011-2016); Observational, longitudinal study of ALS subjects (139 subjects total); CSF, P and S samples available.

Cross-sectional ALS Biofluid (CABB) Study (2015-Ongoing); Observational, multicenter study of ALS, non-ALS neurological controls, PLS/PMA and neurological control subjects; CSF (collected occasionally), P, S, U and WB samples available.

ANSWER ALS Study (2016-Ongoing); Observational, Cross-sectional, longitudinal, multicenter ALS Biofluid Study of ALS, non-ALS neurological controls and PLS/PMA and healthy control subjects; CSF (collected occasionally), P, S, and WB samples available from at least 700 subjects.

Longitudinal Characterization of the FTD-ALS Spectrum (MRI-FTD-ALS); Observational, longitudinal (covering 12 month) study of ALS, FTD/ALS, FTD/Bv, FTD/PPA-sematic, FTD/PPA-PNFA; MRI performed at screening; MRI and blood collection at months 6 and 12). P, S, and WB samples available from 40 subjects.

A Novel Immunosuppression Intervention for the Treatment of ALS (NIPAL2013 2013-2016); Immunosuppressive treatment included: basiliximab, solumedrol, prednisone, tacrolimus and mycophenolate mofetil. MGH site: 10 subjects total (6 subjects with onset ≤24 and 4 subjects with onset > 24 months from Screening Visit. CSF was collected at: Baseline and at 2, 6 and 12 Months. PBMC was collected at Baseline and at Treatment Day 1 at 1, 2, 4, 6, 8 and 12 Months.

Metabolic ALS study: Observational study (2 time points, few days apart) (2012-2015) of 14 ALS, 7 neurological control, 4 Mito and 5 healthy control subjects (male/female: 17/13). P, S and CSF samples available.

NCRI Studies. Please check all that apply. Descriptions of these studies are found in a separate document.

Determination of Biological Markers in Cerebrospinal Fluid of Subjects with Amyotrophic Lateral Sclerosis

Determinants of Disease Severity in Amyotrophic Lateral Sclerosis

Application of a product enhanced reverse transcriptase (PERT) assay to search for evidence of retroviral involvement in amyotrophic lateral sclerosis (ALS)

Metabolomic Signatures in Amyotrophic Lateral Sclerosis

Identification of Diagnostic Biomarkers and Therapeutic Targets for Amyotrophic Lateral Sclerosis

Validation of ALS Metabolomic Biomarkers and Development of ALS Diagnostics

ALS Sample Repository

Legacy samples (collected between 1997-2004) have limited Demographics information available.

Are there any specific requirements for the samples (e.g. time of collection, not taking riluzole, etc) or clinical data (e.g. ALSFRS-R, site of symptom onset, etc)? Yes No

If yes, please list the specific requirements:

 

Experimental Plan

Please provide a brief explanation of your proposed use of the samples. This should include rationale, preliminary data/evidence of feasibility, outline of experimental approach, and justification of sample size and volume. Please limit explanation to no more than two pages.  

Name of assay and brief description of assay method:  

How many replicate assays were performed:  

Typical batch size of assay:  

Coefficient of Variation of quality control samples for this assay (if known):  

Preference for the Plasma anti-coagulant:

Plasma collected in K₂EDTA Tubes (Samples since 2006 and onward)?

Plasma collected in Sodium Heparin Tubes (Samples from 2006 and earlier)?

No preference

Name of analyzing lab (if applicable):  

Name of lab contact person:  

Phone number:   Email address:  

Relevance to ALS

How will the results of your proposed study contribute to advancements in ALS research?

 

What will the results from this study contribute to future studies in the ALS field?

 

How will you interpret your data once your study is complete?

 

Are you a NEALS Member? Yes No

Processing Fees:

-$1,000 for Non-NEALS Members; No fee for NEALS Members

-Samples Processing per sample type for non-NEALS Members and non-academic requests:

Plasma or Serum: $50/0.5mL
Whole Blood: $50/1mL
Urine: $50/1mL
CSF: $100/0.5mL

Public Statement:

Please write up to 100 words about your project that can be displayed publicly to show that we are sharing samples. Otherwise, we will use the following statement:

“The NEALS Biorepository has shared samples with <the Requesters organization> for cutting-edge ALS research.”

 

Funding Information

Potential sample approval is based on the applicant’s demonstration of funding available for the proposed project and dependant on the number of samples in the sample repository at the time of the sample request. Please attach all relevant funding information.

Do you currently have funding for this project? Yes No

The following questions will help us determine what type of sample transfer agreement to utilize.

Will you be receiving compensation of any kind that has a value exceeding the cost of processing,

collecting, and shipping the specimens/patient data? Yes No

Is the recipient scientist planning to use the specimens/patient data in connection with research supported by industry (if you do not know, you will need to find out from the collaborator)? Yes No

Should your application be approved, the Sample Repository Committee requires that you provide a detailed summary statement to the Committee within 6 months of receiving the samples. This progress report must detail how the samples have been used, any resulting data from the study, and list any publications that have occurred because of the study.

Agree to mention NEALS Biorepository in related Publications:

  Yes   No

If YES, please use this Acknowledgement Statement: “We acknowledge the NEALS Biorepository for providing all or part of the biofluids from the ALS, healthy controls and non-ALS neurological controls used in this study”.

Restrictions:

Samples cannot be sold or shared beyond the specified use in the laboratories noted in this request.
Fully executed Letter of Transfer (LoT) or a Materials Transfer Agreement (MTA) will be required prior to samples shipment.

Disclaimer Statements:

The NEALS Biorepository collects and stores cryopreserved biofluids (including Whole Blood, Plasma, Serum, Cerebral Spinal Fluid and Urine) from consenting patients, who have been worked up in neurological detail, at the NEALS affiliated clinical sites. The samples collection and the corresponding clinical information storage and sharing are performed under approved IRB protocols and in accordance with HIPPA.
While we do not knowingly distribute biofluid samples from subjects known to be infectious, it is ultimately the responsibility of the recipient to employ proper biosafety handling techniques.

Please attach an NIH biosketch to this application and submit to:

NEALS Director of Operations

[email protected]

(p) 617-858-4277

NEALS and NCRI Sample Repository Request Form

V7.0 – August 28, 2018

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