University of Southern California

Research

RFA-CA-18-030: Cancer Prevention Clinical Trials Network (CP-CTNet): Data Management, Auditing, and Coordinating Center (DMACC) (U24 Clinical Trial Required)

Slots:                                                     1                             

Internal Deadline:                          Contact the Office of Research if interested

LOI:                                                        October 15, 2018                             

External Deadline:                          November 15, 2018, by 5:00 PM local time of applicant organization.

Award Information:                        Type:  Cooperative Agreement

Estimated Number of Awards: NCI intends to commit $2M in FY 2019 and $3M per year in subsequent years to support one award for the CP-CTNet DMACC.

Anticipated Amount: The requested budget must not exceed $1.25M in direct costs for year 1 and $1.90M in direct costs for subsequent years.

Submission Process:                     PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://app.wizehive.com/webform/USCgrants

Materials to submit:

Link to Award:                                  https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-18-030.html  

Who May Serve as PI:                    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

Purpose:

This Funding Opportunity Announcement (FOA) is one of two FOAs for the National Cancer Institute (NCI)-supported Cancer Prevention Clinical Trials Network (CP-CTNet). The purpose of CP-CTNet is to perform early phase clinical trials to evaluate the biologic effects of preventive agents and interventions and to determine clinically-relevant correlates in order to advance their development for cancer prevention.

CP-CTNet will support the following two types of components that will be individually awarded through the respective FOAs indicated below:

    • CP-CTNet Sites (covered by companion FOA, RFA-CA-18-029), whose role will be to design, perform and report the results of early phase (phase 0-2) cancer prevention clinical trials.
    • CP-CTNet Data Management, Auditing, and Coordinating Center (DMACC) (this RFA).

The CP-CTNet DMACC will support the CP-CTNet Sites and coordinate trans-Network activities with the following specific responsibilities:

(i) centralized data management and data reporting,

(ii) clinical trials auditing, and

(iii) administrative and logistical coordination across CP-CTNet.

To achieve these goals, the DMACC is expected to provide multi-disciplinary expertise in information technology, clinical research informatics, clinical trials auditing, clinical trials methodology and biostatistics, and operations management to support CP-CTNet activities.

The overall goal of CP-CTNet is to perform early phase cancer prevention clinical trials to identify agents and interventions that can advance through the various phases of clinical development. Specific objectives are summarized below:

    • To efficiently design and conduct early phase clinical trials to assess the cancer preventive potential of a variety of different agents or strategies. Emphasis is on novel agents and interventions that target relevant pathways important in carcinogenesis.
    • To characterize the effects of these agents and interventions on their molecular targets, as well as on other biological events associated with cancer development (such as cell proliferation, apoptosis, growth factor expression, oncogene expression, immune response) and correlate these effects with clinical endpoints.
    • To develop further scientific insights into the mechanism of cancer prevention by the agent or strategy examined and to continue to develop novel potential markers as determinants of response.

Visit our Institutionally Limited Submission webpage for updates and other announcements.