Q149-191: Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

Question 149: Did the recipient have known nodal involvement?

Refer to Graphic 1 for identification of nodal areas. Nodal involvement may be assessed by a physician palpating lymph nodes, pathology from a lymph node biopsy, or radiological assessment (e.g., PET or CT imaging). If evidence of nodal involvement is indicated prior to the start of the preparative regimen/infusion, report “yes,” and continue with Question 150. If not, report “no,” and skip question 150.

Graphic 1. Nodal Regions¹

¹ “Lymphadenopathy.” Web log post. Horses and Zebras. Morning Report at Toronto General Hospital, 20 July 2010. Web. 2 May 2012. http://morningreporttgh.blogspot.com/2010/07/lymphadenopathy.html

Question 150: Specify the size of the largest nodal mass

Report the size (measured in centimeters) of the largest known nodal mass. If the size of the largest nodal mass cannot be determined, leave question 150 blank and override the validation error using the code “Unknown.”

Question 151: Was extranodal disease present?

If extranodal involvement was identified at the last evaluation prior to the start of the preparative regimen, indicate “yes” and continue with question 152. If not, report “no” and skip questions 152-155.

For further information on reporting extranodal disease, refer to question 17.

Question 152-155: Specify the site(s) of extranodal involvement

For questions 152-154, indicate whether extranodal involvement was identified for each site. Do not leave any question unanswered. If there was extranodal involvement at a site other than those listed in questions 152-153, report “yes” for question 154 and specify all other sites of involvement in question 155.

Questions 156-157: Prolymphocytes

Indicate whether the percentage of prolymphocytes in the peripheral blood is “known” or “unknown” prior to the start of the preparative regimen (or prior to infusion if no preparative regimen given). If “known,” report the laboratory value documented on the laboratory report. If “unknown,” skip question 157 and continue with question 158.

Question 158-160 Serum β2 microglobulin?

Indicate whether the β2 microglobulin is “known” or “not known” prior to the start of the preparative regimen (or prior to infusion if no preparative regimen given). If “known,” report the laboratory value and unit of measure documented on the laboratory report. If “unknown,” skip questions 159-160.

If known, indicate the upper limit of normal for the serum β2 at the institution where testing was performed.

Indicate the upper limit of normal for β2 microglobulin at the institution where testing was performed.

Questions 161-162: Lymphocytes in bone marrow

Indicate whether the percentage of lymphocytes in the bone marrow is “known” or “not known” prior to the start of the preparative regimen (or prior to infusion if no preparative regimen given). If “known,” report the laboratory value documented on the laboratory report. If “unknown,” skip question 162 and continue with question 163.

Question 163-164: Were tests for molecular markers performed (e.g. PCR)?

Indicate whether molecular testing was done prior to the start of the preparative regimen (or prior to infusion if no preparative regimen given). For further instructions on reporting testing for molecular markers, refer to question 41-42.

If molecular testing was done, report “yes” and indicate the sample collection date in question 164. If the exact date is not known, use the process described for reporting partial or unknown dates in General Instructions, General Guidelines for Completing Forms.

If no molecular testing was performed or it is unknown if testing was done, report “no” or “unknown” respectively and skip questions 165-173.

Questions 165-173: Specify results

For each molecular marker in questions 165-172, report whether testing was “positive,” “negative,” or “not done.” If tests identified a molecular marker other than those listed in questions 165-170, report the result in question 171 and specify the marker in question 172.

If multiple “other molecular markers” were tested at the time of best response, report “see attachment” in question 172 and attach the final reports for any other markers which were tested. In this scenario, report “positive” in question 171 if any of the “other molecular markers” were detected.

Indicate if documentation was submitted to the CIBMTR (e.g., pathology report) in question 173. For further instructions on how to attach documents in FormsNet3^SM, refer to the Training Guide.

Question 174-175: Was disease assessed via flow cytometry (4-minimum color) (immunophenotyping)?

Indicate whether flow cytometry (immunophenotyping) was performed prior to the start of the preparative regimen (or prior to infusion if no preparative regimen given). If “yes,” report the sample collection date in question 175. If the exact date is not known, use the process described for reporting partial or unknown dates in General Instructions, General Guidelines for Completing Forms.

If flow cytometry was not performed during this time period, report “no” and skip question 176.

Question 176: Was disease detected?

Indicate if disease was detected by flow cytometry. If the findings are unclear, consult with a physician and have them document whether evidence of disease is present.

Question 177: Were cytogenetics tested (karyotyping of FISH)?

Indicate if karyotyping or FISH studies were obtained prior to the start of the preparative regimen (or prior to infusion if no preparative regimen given). For further information on reporting karyotyping and FISH assessments, refer to questions 61-62.

If “yes,” continue with question 178. If “no,” skip questions 178-188.

Question 178: Results of tests

If chromosomal abnormalities were detected, indicate “abnormalities identified,” and continue with question 179. If cytogenetic studies yielded “no evaluable metaphases” or there were “no abnormalities” identified, continue with question 189 and leave questions 179-188 blank.

Questions 179-188: Specify results

For each cytogenetic abnormality, report whether testing was positive (yes) or negative (no). Refer to question 62 for further information on how to determine if a testing is positive or negative for a clonal abnormality. If an abnormality was detected, but cannot be reported in question 179-186, report “yes” for question 187 and specify any abnormalities detected and not already reported above in question 188.

Question 189-190: Was the disease assessed by clinical/hematologic assessment?

Clinical and hematologic assessments are the least sensitive methods of establish a patient’s disease status. Examples of those include: pathologic evaluation (e.g., bone marrow biopsy), radiographic examination (e.g., X-ray, CT scan, MRI scan, PET scan), and laboratory assessment (e.g., CBC, peripheral blood smear), in addition to clinician evaluation and physical examination.

If clinical and/or hematologic assessment were performed at the time of disease assessment prior to the start of the preparative regimen (or prior to infusion if no preparative regimen given), report “yes” and report the date of assessment in question 90. For further information on reporting the date of clinical/hematologic assessment, refer to questions 144-145.

If no clinical and/or hematologic assessments were performed at the time of disease assessment prior to the start of the preparative regimen (or prior to infusion if no preparative regimen given), report “no” and skip question 191.

Question 191: Was disease detected?

Indicate if disease was detected by clinical/hematologic assessment. If the findings are unclear, consult with a physician and have them document whether evidence of disease is present.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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