SOW_2.pdf

April 15, 2024

Attachment 1 - Statement of Work

Pediatric Proton and Photon Therapy Comparison Cohort Coordinating Center

1.0 BACKGROUND

The Radiation Epidemiology Branch (REB), Division of Cancer Epidemiology and Genetics

(DCEG), National Cancer Institute (NCI) carries out studies to quantify second cancer risks associated with ionizing radiation exposures in pediatric cancer patients. The Branch has a specific interest in the risk of second tumors following proton therapy in children, because concerns have been raised about whole-body scatter doses from neutrons, brain necrosis and other late effects including second tumors.

Pediatric radiation oncology is undergoing rapid changes due to the widespread introduction of proton therapy. By reducing high-dose exposure to nearby normal tissue protons should reduce a wide-range of serious adverse-effects, such as second cancers. To date, no studies have directly evaluated the potential benefits or risks of protons for children, and some case series have raised concerns about some serious unanticipated side-effects, such as brain necrosis. There is widespread agreement amongst the clinical and scientific community that large-scale collaborative efforts are urgently required to address these questions. The REB/DCEG aims to create the first prospective cohort study including pediatric cancer patients treated with proton therapy and a comparison group of similar patients treated with photon therapy. This new cohort will build upon a foundation created by the US Pediatric Proton Consortium Registry (PPCR).

This state-of-the-art registry currently includes 18 US proton therapy centers and has recruited more than 4,000 pediatric proton patients who have actively enrolled in the registry since 2012.

Thus, the coordinating center study team has developed infrastructure and expertise critical to management of contributing study centers, oversight and facilitation of data collection processes, and content-specific quality control and quality assurance. For the Pediatric Proton and Photon

Therapy Comparison Cohort, there is a critical need to obtain consistent and complete data from proton patients and a control group of patients treated with photon therapy, which will allow for comparisons between patients treated with proton versus photon therapy. To obtain data on a sufficient number of proton and photon therapy patients, data will need to be obtained from multiple different proton and photon therapy centers, requiring a coordinating center to ensure uniform procedures and systems for data handling across the centers. Data from the PPCR will be incorporated into the new cohort study, so it is important that equivalent data is obtained from proton and photon centers using the same procedures and systems. The purpose of this acquisition is to obtain the services of a coordinating center for the Pediatric Proton and Photon

Therapy Comparison Cohort that will support the assembly of data for a group of proton or photon treated pediatric cancer patients from multiple institutions, to supplement an existing cohort of proton-treated pediatric patients that is maintained by the contractor, in order to evaluate the risks of second cancers in pediatric patients treated with photons versus protons.

2.0 OBJECTIVE

The Contractor shall assemble existing data from medical records for a group of pediatric cancer patients who received proton or photon therapy. The objective is to acquire a high-quality data set through uniform acquisition of standard data elements across multiple participating proton and photon treatment centers, with data acquired so that it is consistent with similar data from proton-treated patients in the PPCR. Data obtained will be used to compare outcomes in patients treated with proton versus photon therapy.

3.0 SCOPE

The Contractor shall facilitate and monitor data acquisition by individual hospital centers where pediatric cancer patients have been treated with protons or photons in order to form a cohort of data from medical records. The Contractor shall maintain and manage a data platform that mirrors the platform used in the PPCR for acquisition and storage of de-identified proton and photon patient data, provide training and access to study staff at participating centers, provide guidance and assistance as needed to study staff at participating institutions, implement quality control processes to ensure collection of high quality data, and provide summary reports of data obtained. The Contractor shall provide technical and informational assistance to individual centers to define, access, de-identify, and upload copies of required radiotherapy and imaging data, to be comparable to the proton radiotherapy and imaging data in the PPCR.

4.0 CONTRACT REQUIREMENTS

The Contractor shall perform the following tasks:

4.1 Coordinate and monitor data collection from existing medical records for eligible pediatric cancer patients treated with proton or photon therapy at participating hospital centers. This shall include orientation of staff at participating sites to the data requirements for the study and institution of procedures that will result in the systematic collection of de-identified medical and radiotherapy treatment data from existing medical records of eligible patients.

Orientation and monitoring activities will typically occur via email communication, teleconference or video conference, with travel to the participating centers considered on an as-needed basis to monitor study progress and data quality.

4.2 Assign unique study participant IDs to all eligible pediatric cancer patients treated with proton or photon therapy to facilitate creation of a cohort of data from medical records.

4.3 Monitor data collection progress and provide guidance to study staff at participating institutions through regular communication and virtual meetings. In-person site visits shall not be required but can be considered on an as-needed basis.

4.4 Maintain a data acquisition and storage system to house de-identified data for a multi-center cohort of pediatric patients treated with protons or photons. Provide access and training to participating centers.

4.5 Maintain systems for data collection and transfer of de-identified radiotherapy plans, images and dose data. Provide access and training to participating centers.

4.6 Monitor data obtained from participating centers regularly for quality and completeness across all participating sites. Consult with study centers, if needed, to provide guidance and facilitate resolution of data quality issues or questions about collection of specific data elements. Provide NCI with quarterly progress reports to show progress of data collection and notify NCI of missing data fields or other data quality issues.

4.7 Consult with study centers, if needed, to review archived and current radiotherapy plans.

The Contractor shall provide guidance and technical support to participating centers to facilitate collection and de-identification of final radiotherapy plans at participating hospital sites. This work, to be performed by the participating sites, may include locating and unarchiving older radiotherapy plans. The Contractor shall provide support for centers to upload these plans for transfer to the Contractor’s system.

5.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

The Contractor shall submit Quarterly Progress Reports describing the general progress of the work and any problems encountered. The Quarterly Progress Report shall also include a numerical summary of the number of proton and photon patients with deidentified data collected into the Contractor’s data collection system from each participating hospital or institution. The first quarterly report shall cover the first full three months of the contract, in addition to any fractional part of the initial month. Thereafter, reports shall be submitted on a quarterly basis.

Reports shall be due thirty (30) calendar days after the end of the reporting period. A fourth quarterly report will not be required for the period when an annual report or final report is due.

At the conclusion of data collection (due by 15 calendar days before expiration date or as agreed upon by the Contractor and NCI), the Contractor will provide a data set to the NCI containing de-identified individual-level data for patients treated with protons or photons. The NCI shall review the deliverables submitted by the Contractor for acceptance within 14 calendar days of receipt and approve the submitted reports. At the completion of the review, the NCI’s technical point of contact shall notify the Contractor as to the acceptability of the deliverable. If any changes or revisions are required of the Contractor, the revised deliverables shall be submitted to

NCI within 5 calendar days of the date of notification. If no comments or request for revisions are provided within 14 calendar days, the deliverables will be considered acceptable. In general, the NCI’s technical point of contact will provide technical scientific review and approval of all deliverables submitted by the Contractor.

All deliverables shall be sent electronically per the following schedule:

Table of deliverables – Pediatric Proton and Photon Therapy Comparison Cohort Coordinating

Center

Deliverable Description Due Date Delivery Location

#1 Quarterly

Progress

Report

Report shall include a brief qualitative description of the general progress of the work and any problems encountered, and also a numerical report of the number of proton and photon patients abstracted at each center to date.

Due within thirty (30) calendar days after three (3) months of performance

Central Point of Distribution:

ncibranchbinvoices@mail.nih.gov

Contracting Officer (CO):

randy.cook@nih.gov

Contracting Officer’s

Representative (COR) & SME:

stinek@exchange.nih.gov;

todd.gibson@nih.gov

#2 Quarterly

Progress

Report

Report shall include a brief qualitative description of the general progress of the work and any problems encountered, and also a numerical report of the number of proton and photon patients abstracted at each center to date.

Due within thirty calendar

(30) days after six (6) months of performance stinek@exchange.nih.gov;

todd.gibson@nih.gov

#3 Quarterly

Progress

Report

Report shall include a brief qualitative description of the general progress of the work and any problems encountered, and also a numerical report of the number of proton and photon patients abstracted at each center to date.

Due within thirty calendar

(30) days after nine (9) months of performance stinek@exchange.nih.gov;

todd.gibson@nih.gov

#4 Annual

Report

Report shall include a summary description of the work performed and a numerical summary to include the total number of proton and photon patients abstracted at each center, overall and by calendar year of diagnosis and by type of cancer diagnosis.

Due within thirty (30) calendar days after twelve

(12) months of performance stinek@exchange.nih.gov;

todd.gibson@nih.gov

#5 Quarterly

Progress

Report

Report shall include a brief qualitative description of the general progress of the work and any

Due within thirty (30) calendar days after fifteen

Central Point of Distribution:

ncibranchbinvoices@mail.nih.gov mailto:ncibranchbinvoices@mail.nih.gov mailto:randy.cook@nih.gov mailto:stinek@exchange.nih.gov mailto:todd.gibson@nih.gov mailto:ncibranchbinvoices@mail.nih.gov mailto:%20randy.cook@nih.gov mailto:stinek@exchange.nih.gov mailto:todd.gibson@nih.gov mailto:ncibranchbinvoices@mail.nih.gov mailto:%20randy.cook@nih.gov mailto:stinek@exchange.nih.gov mailto:todd.gibson@nih.gov mailto:ncibranchbinvoices@mail.nih.gov mailto:%20randy.cook@nih.gov mailto:stinek@exchange.nih.gov mailto:todd.gibson@nih.gov mailto:ncibranchbinvoices@mail.nih.gov problems encountered, and also a numerical report of the number of proton and photon patients abstracted at each center to date.

(15) months of performance stinek@exchange.nih.gov;

todd.gibson@nih.gov

#6 Quarterly

Progress

Report

Report shall include a brief qualitative description of the general progress of the work and any problems encountered, and also a numerical report of the number of proton and photon patients abstracted at each center to date.

Due within thirty (30) calendar days after eighteen

(18) months of performance stinek@exchange.nih.gov;

todd.gibson@nih.gov

#7 Quarterly

Progress

Report

Report shall include a brief qualitative description of the general progress of the work and any problems encountered, and also a numerical report of the number of proton and photon patients abstracted at each center to date.

Due within thirty (30) calendar days after twenty-one (21) months of performance stinek@exchange.nih.gov;

todd.gibson@nih.gov

#8 Final Report Report shall include a summary description of the work performed and a numerical summary to include the total number of proton and photon patients abstracted at each center, overall and by calendar year of diagnosis and by type of cancer diagnosis.

15 calendar days before expiration date.

stinek@exchange.nih.gov;

todd.gibson@nih.gov

#9 Final Data

Set

Data set containing de-identified individual-level data for patients treated with protons and photons.

15 calendar days before expiration date.

Evidence of submission to mailto:randy.cook@nih.gov mailto:stinek@exchange.nih.gov mailto:todd.gibson@nih.gov mailto:ncibranchbinvoices@mail.nih.gov mailto:%20randy.cook@nih.gov mailto:stinek@exchange.nih.gov mailto:todd.gibson@nih.gov mailto:ncibranchbinvoices@mail.nih.gov mailto:%20randy.cook@nih.gov mailto:stinek@exchange.nih.gov mailto:todd.gibson@nih.gov mailto:ncibranchbinvoices@mail.nih.gov mailto:%20randy.cook@nih.gov mailto:stinek@exchange.nih.gov mailto:todd.gibson@nih.gov mailto:ncibranchbinvoices@mail.nih.gov mailto:Linda.park@nih.gov stinek@exchange.nih.gov;

todd.gibson@nih.gov mailto:stinek@exchange.nih.gov mailto:todd.gibson@nih.gov