Question 89-90: Were tests for molecular markers performed (e.g. PCR)?
If testing for molecular markers was performed during the reporting period, report “yes” and report the sample collection date of the most recent testing performed during the reporting period in question 90. If the exact date is not known, use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.
If testing for molecular markers was not performed during the reporting period, report “no” or “unknown” and continue with question 99.
For more information on testing for molecular markers, refer to the instructions for questions 4-5.
Questions 91-98: Specify results
For each molecular marker in questions 91-97, report whether the most recent testing performed during the reporting period was “positive,” “negative,” or “not done.” If tests identified a molecular marker other than those listed in questions 91-96, report the result in question 97 and specify the marker in question 98.
If multiple “other molecular markers” were tested at the time of evaluation for this reporting period, report “see attachment” in question 98 and attach the final reports for any other markers which were tested. For further instructions on how to attach documents in FormsNet3SM, refer to the Training Guide.
Question 99-100: Was the disease status assessed via flow cytometry (minimum 4-color flow) (immunophenotyping)?
If flow cytometry (immunophenotyping) was performed during the reporting period, report “yes” and indicate the sample collection date of the most recent testing performed during the reporting period in question 100. If the exact date is not known, use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.
If flow cytometry (immunophenotyping) was not performed during the reporting period, report “no” and skip questions 100-101.
For more information on reporting flow cytometry, refer to the instructions for questions 14-15.
Question 101: Was disease detected?
Indicate whether disease was detected by the most recent flow cytometry assessment performed during the reporting period. If the findings are unclear, consult with a physician and have them document whether evidence of disease is present.
Question 102: Was the disease status assessed by cytogenetic (karyotyping or FISH)?
Indicate whether cytogenetic studies (karyotyping or FISH) were obtained during the reporting period. If cytogenetic studies were obtained, report “yes” and continue with question 103. If not, report “no” and skip questions 103-108.
For more information on reporting karyotyping and FISH studies, refer to the instructions for question 17.
Question 103-104: Was the disease status assessed via FISH?
If FISH studies were performed during the reporting period, report “yes” and indicate the sample collection date of the most recent testing performed during the reporting period in question 104. If the exact date is not known, use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.
If FISH studies were not performed, report “no” and skip questions 104-105. Examples of this include: no FISH study performed or FISH sample was inadequate.
Question 105: Was disease detected?
Indicate whether disease was detected by the most recent FISH study performed during the reporting period. If the findings are unclear, consult with a physician and have them document whether evidence of disease is present.
Question 106-107: Was the disease status assessed via karyotyping?
If conventional cytogenetic studies were obtained during the reporting period, report “yes” and report the sample collection date of the most recent testing performed during the reporting period in question 107. If the exact date is not known, use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.
If conventional cytogenetic studies were not performed, report “no” and continue with question 109. Examples of this include: no conventional cytogenetics performed or conventional cytogenetic culture failed.
Question 108: Was disease detected?
Indicate whether disease was detected by the most recent karyotyping study performed during the reporting period. If the findings are unclear, consult with a physician and have them document whether evidence of disease is present.
Question 109-110: Was the disease status assessed by clinical/hematologic assessment?
Indicate whether any clinical and/or hematologic assessments were performed during the reporting period. If “yes,” report the date of assessment in question 110. The date reported should be that of the most-disease specific assessment performed within approximately 30 days of the date of contact (reported on the Post-Infusion Data Form). When determining the most disease-specific assessment, only consider studies which have previously or currently show evidence of disease. If all assessments are negative, report the date of the most sensitive test performed (e.g., report a bone marrow biopsy rather than a CBC) within the appropriate time period. If assessments are positive for disease, report the most recent positive assessment. If the exact date is not known, use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.
If no clinical and/or hematologic assessments were performed during this time period, report “no” and skip questions 110-111. This option should rarely be reported given the inclusion of physician assessments.
For more information on reporting clinical/hematologic assessments, refer to the instructions for questions 24-25.
Question 111: Was disease detected?
Indicate whether disease was detected by clinical/hematologic assessment on the date reported in question 110. If the findings are unclear, consult with a physician and have them document whether evidence of disease is present.
Question 112: What is the current disease status?
Report the recipient’s disease status at the time of evaluation for this reporting period. Ensure the disease status is consistent with the international working group criteria provided in the in CLL Response Criteria section of the Forms Instructions Manual. If the disease was not assessed, report “not assessed” and go to “First Name.” This option should rarely be used given the inclusion of physician assessments as disease evaluations.
The center does not need to repeat all disease-specific assessments (biopsies, scans, labs) each reporting period in order to complete current disease status data fields. Once a particular disease status is achieved, the center can continue reporting that disease status (based on labs / clinical assessments) until there is evidence of relapse / progression.
Question 113: Date assessed
The date reported should be that of the most-disease specific clinical / hematologic assessment performed within approximately 30 days of the date of contact (reported on the Post-Infusion Data Form). When determining the most disease-specific assessment, only consider studies which have previously or currently show evidence of disease. If all assessments are negative, report the date of the most sensitive test performed (e.g., report a bone marrow biopsy rather than a CBC) within the appropriate time period. If assessments are positive for disease, report the most recent positive assessment. If the exact date is not known, use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.
Section Updates:
| Question Number | Date of Change | Add/Remove/Modify | Description | Reasoning (If applicable) |
|---|---|---|---|---|
| . | . | . | . | . |
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