NCI Best Case Series Protocol

As part of the NCI Best Case Series Program, this protocol enables CRISP staff to work with CAM practitioners to identify appropriate, well-documented cancer cases. The primary goal of this protocol is to obtain and review sufficient information to determine if NCI-initiated research is warranted on a specific intervention.

• What are the NCI Best Case Series Protocol Eligibility Criteria?
• How do I compile an optimal best case series case summary and case study?
• What constitutes CAM?
• NCI BCS Protocol Flow Chart
• NCI Best Case Series Protocol Timeline
• Protocol Outcomes
• FAQs about the BCS Protocol
• Promote the NCI Best Case Series Protocol

NCI Best Case Series Protocol Eligibility Criteria

• Pathologically or cytologically confirmed diagnosis of cancer
• Treatment with an alternative approach exclusively or ≥ 4 weeks after conventional treatment
• Detectable disease prior to the start of the alternative treatment
• Adequate documentation in the medical records of conventional and alternative regimens, and dates of interventions
• Identifiable, objective changes in the malignancy during time of treatment

Compiling a NCI Best Case Submission

Patient Consent to Release Contact Information

For those practitioners interested in presenting a “Best Case Series” to the Protocol the first step is to submit the appropriate de-identified cases (see below). If NCI OCCAM deems these cases eligible for review based on the protocol criteria, the practitioner is notified to obtain the patient’s consent to have NCI OCCAM contact those patient(s). The patient consent to release this contact information can be downloaded as a pdf below. Upon OCCAM’s receipt of this consent and the patient’s contact information, NCI OCCAM contacts the patient(s) via telephone to explain the NCI Best Case Series Protocol, answer any questions the patient may have, obtain protocol consent, and finally confirm the medical history, including alternative therapies.

Download the Consent to Release of Contact Information (pdf)

Case Summary Format

Pre-Research

De-identified Summary

The following is a sample Case Report Format used to submit a NCI BCS Case Summaries Please adhere to the suggestions below. You may alter the format but include as much of the indicated content as possible.

Patient Code:

Diagnosis (as verified by biopsy):

History

• History of present illness with presenting symptoms
• Significant medical history especially previous cancer diagnosis
• Alternative treatment interventions (method, dates, response, treating facility, primary providers)
• Complete list of over the counter and prescription medications
• Current Status of the patient
• Detectable disease prior to the start of the alternative therapy
• Identifiable, objective changes in the malignancy during time of treatment
• Written description of pathological diagnosis and available imaging

Research

Identified Medical Records

• Operative Reports
• Discharge Summaries
• Radiation Oncology, Surgical Oncology, Chemotherapy treatment notes
• Laboratory Reports if critical in following disease progression (tumor markers, IgG, etc)

Pathology

• All anatomic pathology, cytology, immunology reports to verify the sites of involvement of the cancer
• Bone marrow aspirate and biopsy reports
• Documents must have patient's name, specimen number, date, and treatment facility

Radiology

For all diagnostic reports surrounding initial diagnosis and subsequent restaging of disease, special attention will be paid to:

• Reports of pre- and post- conventional treatment imaging studies
• Reports of pre- and post- CAM intervention
• If clinical course extends for years, provide reports of selected, representative studies
• If disease recurrence occurs, include all reports surrounding re-evaluation
• Contact Information: Patient name, address, and phone number (all locations if patient has more than one residence
• Primary Care Provider and treating facilities names, addresses, and phone numbers throughout conventional and CAM treatment regimens
• If the patient is no longer living, please verify family member’s willingness to consent to the NCI evaluation process

Please include a copy of the Medical Records Release Authorization form signed by the patient or family member.

Protocol Outcomes:

• Potential recommendation for NCI-initiated research
• Potential publication of NCI review in a peer-reviewed journal

Frequently Asked Questions about the
NCI Best Case Series Protocol

Does the NCI Best Case Series Program evaluate CAM therapies for their effectiveness as a cancer treatment?

No. An evaluation of a treatment's effectiveness is generally done by analyzing the results of well-designed and well-conducted clinical trials. Rather, the goal of the NCI Best Case Series Program is to provide an assessment of the quality of available data and its utility as support for the justification of NCI-initiated research.

What is the minimum number of case summaries to include in my submission to the NCI Best Case Series Protocol?

If you have complete documentation of 3 to 20 patient cases for a particular cancer that has responded to an alternative therapy, CRISP would like to hear from you. We will review each case submitted to us to determine which ones are optimal for development into case summaries.

Sometimes there are costs associated with acquiring medical records, radiographic imaging, or pathologic slides/blocks for patients. Who pays for this?

The costs of duplicating medical records and radiographic imaging studies are incurred by the preparer of the case submission. Most often, radiographic imaging and pathologic slides/blocks are borrowed with the understanding that they will be returned following the review. If after initial review OCCAM determines that a particular case is very important to the successful completion of your case series, then we will offer to try to assist you in obtaining the documentation.

Will NCI protect my patients’ confidentiality?

While research documents submitted for review must have full patient identifiers, all efforts will be made to protect patient confidentiality. Selected NCI and NIH staff will have access to these materials.

I’m a patient who used an alternative therapy to cure my cancer. How can I participate in the NCI BCS Protocol?

If you are a patient who has a confirmed diagnosis of cancer and are currently, or have previously been, treated with an alternative regimen, you may be eligible to have your case report reviewed as part of the the NCI Best Case Series protocol. Although your oncologist must review the case eligibility criteria and prepare the summary for submission, you may initiate the process by bringing the protocol to their attention. By sharing your successful treatment experience with the research community, you could help in the development of innovative therapies for future patients.