Welcome to the URCC NCORP Research Base Website
URCC10054 Curcumin Study Amendment 2 PDF Print E-mail
Written by Sebastien Estaque   
Tuesday, 28 June 2011 08:08

Amendment 2 dated 6/15/11 is ready for you to download and submit to your IRBs. 


The changes incorporated in Amendment 2 are the result of questions and feedback that we have received from you, our CCOP affiliates, over the last few months.  This amendment should clarify procedures and reduce data collection errors for you, and scanning problems for us here at the research base.  The protocol, consent form for blood draw, and many of the data collection forms have changed as a result of this amendment.

Please download and submit to your IRBs for approval. If you have any problems downloading these documents, please contact This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Last Updated on Tuesday, 28 June 2011 08:12
 
URCC Research Base Presentations and Posters at ASCO 2011 PDF Print E-mail
Written by Sebastien Estaque   
Tuesday, 31 May 2011 10:54

For those of you who are attending ASCO , you can see the list of presentations /posters from the URCC CCOP Research Base here: icon ASCO 2011- URCC Presenters-Posters

Last Updated on Tuesday, 31 May 2011 10:56
 
URCC10055 Cognitive Study Open PDF Print E-mail
Written by Sebastien Estaque   
Tuesday, 17 May 2011 12:42

URCC10055:  ASSESSMENT OF COGNITIVE FUNCTION IN BREAST CANCER AND LYMPHOMA PATIENTS RECEIVING CHEMOTHERAPY AT PRE-TREATMENT, POST-TREATMENT AND AT SIX MONTH FOLLOW-UP

 is now open

You can download all documents and submit to your IRBs. To download, you must first log in, click on Active Protocols on the Main Menu, then click on Cognitive (10055). Under Categories, you will find:

·       Regulatory Forms that includes the protocol (pdf), model consent form in Word format and a PDF of all study forms for submission to your IRB.

·       On Study & Assessment Packets where all study forms are arranged into “packets” so that you can download each packet as you need them.  There are four packets:  On Study (i.e., On Study Data/Participant Form, Eligibility Checklist, etc.) and Assessments 1, 2 and 3.  These forms contain prefilled assessment numbers at the top of the page and should be used at the corresponding assessment time.  There is a cover sheet with each packet that includes a checklist of everything you will need to do at on-study and at each assessment.  

·       Instructional videos for the computerized CANTAB assessment and blood handling procedures

·       Complete list of forms where each form can be downloaded individually

·       And finally, Supporting Documents includes the blood requisition form and the two manuals for cognitive testing and blood procedures. 

 

Once the URCC receives your IRB approval document and approved consent form:

·       required study materials (computer, blood draw kits, etc) and will be shipped to you within 48 hours. 

·       Each person administering the cognitive tests must be trained.  This training will involve review of the computerized and paper/pencil tasks.  After the training is completed, practice all computerized and paper and pencil cognitive assessments, and email a test copy of your computerized results to This e-mail address is being protected from spambots. You need JavaScript enabled to view it . We will confirm receipt of the practice copy and forward an approval. Once approved, you may begin assessing participants on study.  

·         Many of you received training in the computerized cognitive testing at our annual meeting last September, or were trained during a URCC on-site audit.  You can review the training videos on our website, and/or schedule a teleconference to go over the testing.  Then you can submit a sample test.

·         For those who did not receive the training, you can contact Jennifer Yates at This e-mail address is being protected from spambots. You need JavaScript enabled to view it to schedule a teleconference.  You can then practice and submit the sample copy of your computerized assessment results to the URCC CCOP Research Base.

·       You will also need training in blood handling procedures.  If you have previously received this training as part of the EXCAP study, you do NOT need to schedule another training.

 

Training will also be provided at this year’s URCC annual meeting.  

 

You will receive 1.0 credit per participant accrued.

Last Updated on Friday, 20 May 2011 11:50
 
EXCAP Amendments 4 and 5 ready PDF Print E-mail
Written by Sebastien Estaque   
Monday, 24 January 2011 15:15

Amendments 4 and 5 have been uploaded to the website and are ready for you to download and submit to your IRBs.

Amendment 4

The changes in Amendment 4 were discussed at the annual meeting in September and are the result of supplemental funding obtained by URCC to add actigraphy and to assess cytokines in the ongoing protocol.  These supplements have resulted in several changes to the protocol (sections 2.0, 6.0, 7.0 and 9.0), and changes to the daily diaries, Patient Contact Forms, Clinical Record Information, and consent form; all changes are outlined in a summary document included with the amendment.

Also included with this amendment are a Blood Procedures Operations Manual and Actigraphy Manual.  Additionally, detailed videos to supplement the manuals are located on the URCC website.  You will need to contact Jen Yates ( This e-mail address is being protected from spambots. You need JavaScript enabled to view it or 585.275.6303) to schedule a phone call to update participating staff on the procedures for actigraphy and handling the blood samples prior to accruing to the amended protocol.

 

Once amendment 4 is approved, you will receive 1.5 credits for each new study participant accrued, an increase of 0.5 credits from the original protocol.

 

Amendment 5 is the result of CTEP’s CTCAE conversion plan, which mandates that each protocol mention CTCAE v. 4.0.  We were required to submit this amendment separately from Amendment 4.  You may submit both amendments to your IRB at the same time.

Last Updated on Monday, 24 January 2011 15:18
 
Oral Curcumin for Radiation Dermatitis in Breast Cancer Patients PDF Print E-mail
Written by Sebastien Estaque   
Thursday, 03 February 2011 20:24

Oral Curcumin for Radiation Dermatitis in Breast Cancer Patients

is now open and is available on this website.  You can now download all documents and submit to your IRBs. To download, you must first log in, click on Active Protocols on the Main Menu, then click on Curcumin. The last bullet under Supporting Documents is a PDF of the protcol, the Investigator's Brochure and the forms you will need to submit to your IRB. The second and third bullets under the Regulatory Forms section are the 2 consent forms in Word format; this is so you can modify them to comply with your institution's required wording. One is a consent to participate in the study and the other is a consent to draw blood, which is required for the first 100 patients registered on study.

Once URCC receives your IRB approval document and approved consent form, we will send you a supply of curcumin and a study initiation kit with blood draw and photography supplies and instructions.  You may begin accruing patients upon receipt of these supplies.

You will receive 1.0 credit per participant accrued.
Last Updated on Thursday, 03 February 2011 20:32
 
URCC07004 (ATTRACT-CPN) Closed to accrual PDF Print E-mail
Written by Sebastien Estaque   
Tuesday, 31 August 2010 17:43

URCC07004:  Assessment of Topical Treatment Response with Amitriptyline and Ketamine: Combination Trial in Chemotherapy Peripheral Neuropathy (ATTRACT-CPN)

 

is now closed to accrual as of August 31st

Last Updated on Tuesday, 31 August 2010 17:57
 
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