Q234 – 288: Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion

*Disease Assessment at Last Evaluation Prior to the Start of the Preparative Regimen / Infusion
All values reported must reflect the most recent testing prior to the start of the preparative regimen / lymphodepleting therapy (or infusion if no preparative regimen / lymphodepleting therapy was given). Do not report testing performed during a line of therapy reported above. If testing was not performed near the start of the preparative regimen / lymphodepleting therapy / infusion (within approximately 30 days) and after the most recent line of therapy (if applicable), the report No.

Question 234: Were cytogenetics tested (karyotyping or FISH)?

Cytogenetics is the study of chromosomes. This assessment involves testing blood or bone marrow for known chromosomal abnormalities that reflect the recipient’s disease. For more information about cytogenetic testing and terminology, see Appendix C: Cytogenetics.

Indicate if cytogenetic studies were obtained at the last evaluation prior to the start of the preparative regimen / lymphodepleting therapy (or infusion).

Questions 235 – 236: Were cytogenetics tested via FISH?

Specify if FISH studies were performed at the last evaluation prior to the start of the preparative regimen / lymphodepleting therapy (or infusion) and indicate if abnormalities were detected.

If FISH studies were not performed at the last evaluation, or if FISH samples were inadequate or the results ‘failed,’ report No.

See Appendix C: Cytogenetics, for assistance interpreting FISH results.

Questions 237 – 258: Specify FISH abnormalities

For each abnormality specify if it was detected via FISH at the last evaluation.

• Report Yes if the abnormality was detected at the last evaluation
• Report No if the abnormality was assessed and not detected at the last evaluation
• Report Not done if the abnormality was not assessed or could not successfully be performed at the last evaluation

If a clonal abnormality is detected, but not listed as an option, select Yes for Other abnormality and specify the abnormality. If multiple other abnormalities were detected, report “see attachment” and attach the final report(s) for any other abnormalities detected.

For further instructions on how to attach documents in FormsNet3^SM, refer to the Training Guide.

Question 259: Was documentation submitted to the CIBMTR? (e.g., FISH report)

Indicate if a FISH testing report is attached to support the findings reported above.

For further instructions on how to attach documents in FormsNet3^SM, refer to the Training Guide.

Questions 260 – 261: Were cytogenetics tested via karyotyping?

Specify if karyotyping was performed at the last evaluation and specify if abnormalities were detected. If karyotyping failed or the sample was inadequate, select Yes and specify the results as No evaluable metaphases.

If karyotyping was not performed at the last evaluation or unknown if completed, report No.

See Appendix C: Cytogenetics, for assistance interpreting karyotype results.

Questions 262 – 263: Specify karyotyping abnormalities (check all that apply)

Select all abnormalities detected by karyotyping at the last evaluation. If a clonal abnormality is detected, but not listed as option, select Other abnormality and specify the abnormality. If multiple other abnormalities were detected, report “see attachment” and attach the final report(s) for any other abnormalities detected.

For further instructions on how to attach documents in FormsNet3^SM, refer to the Training Guide.

Question 264: Was documentation submitted to the CIBMTR? (e.g., karyotyping report)

Indicate if a karyotyping report is attached to support the findings reported above.

For further instructions on how to attach documents in FormsNet3^SM, refer to the Training Guide.

*Laboratory Studies at Last Evaluation
The laboratory studies at the last evaluation will be enabled / disabled in FormsNet3^SM based on the histology identified at transformation or at diagnosis (if a transformation did not occur), as reported above.

Questions 265 – 268: Laboratory studies at last evaluation

For each laboratory study, indicate if the test result was known at the last evaluation. If Known, report the result and the unit of measure, if applicable.

All values reported from last evaluation must reflect testing performed after the last line of therapy. If testing was not performed near the start of the preparative regimen / lymphodepleting therapy / infusion (within approximately 30 days) and after the most recent line of therapy (if applicable), the report Unknown.

• Hemoglobin (follicular and all Hodgkin histologies): Hemoglobin is a molecule in red blood cells that delivers oxygen to tissues throughout the body. A low hemoglobin count is considered “anemia” and blood transfusions or growth factors may be required to increase the hemoglobin level.
• Absolute lymphocyte count (all Hodgkin histologies): The total number of lymphocytes, a subtype of white blood cells.

Question 269: Was minimal residual disease (MRD) assessed during the pre-HCT or pre-infusion evaluation?

Minimal residual disease assessments include flow cytometry, PCR, and next generation sequencing.

Indicate if testing was performed by any of these three methods on blood, bone marrow, or any other specimen at the last evaluation.

Questions 270 – 273: Flow cytometry

If MRD was assessed via flow cytometry at the last evaluation, specify the results. If testing was Positive, report the sample source and the date the sample was collected.

If the date is partially known, use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.

Questions 274 – 277: PCR

If MRD was assessed via PCR at the last evaluation, specify the results. If testing was performed for multiple disease markers and any of the markers were detected, report Positive and specify the sample source along with the date the sample was collected.

If the date is partially known, use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.

Questions 278 – 281: Next generation sequencing (NGS, 3rd gen)

If MRD was assessed via next generation sequencing (NGS, 3rd gen) at the last evaluation, specify the results. If testing was performed for multiple disease markers and any of the markers were detected, report Positive and specify the sample source along with the date the sample was collected.

If the date is partially known, use the process for reporting partial or unknown dates as described in the General Instructions, General Guidelines for Completing Forms.

Question 282: Was documentation submitted to the CIBMTR? (e.g., path report)

Indicate if documentation is attached to support the findings reported above.

For further instructions on how to attach documents in FormsNet3^SM, refer to the “ Guide.

Question 283: Did the recipient have known nodal involvement? (at last evaluation)

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).

Indicate if nodal involvement was detected at the last evaluation. If nodal involvement was not detected, or it is unknown if detected, report No.

Question 284: Specify total number of nodal regions involved (follicular only)

Lymph node regions or groups occur above and below the diaphragm. Nodal regions include cervical (neck), axillary (underarm), mediastinal (thoracic), mesenteric (abdominal), para-aortic (pelvic), inguinal (groin), epitrochlear (inside of arm just above elbow), and popliteal (back of knee). Indicate the total number of nodal regions with evidence of lymphoma involvement. Refer to Graphic 1. Nodal Areas below for identification of nodal areas and specific nodes within each area.

Specify the total number of nodal regions involved at the last evaluation.

Graphic 1. Nodal Areas¹

¹ “Lymphadenopathy.” Web log post. Horses and Zebras. Morning Report at Toronto General Hospital, 20 July 2010. Accessed on 9/22/2013 at http://morningreporttgh.blogspot.com/2010/07/lymphadenopathy.html

Questions 285: Specify the size of the largest nodal mass

Report the size of the largest known nodal mass at the last evaluation (as measured in centimeters). If the mass is given in three dimensions (for example: 3 cm x 5 cm x 4 cm), report the longest two dimensions.

Question 286: Was there any known extranodal or splenic involvement? (at last evaluation)

Extranodal refers to the presentation of lymphoma outside of the lymph nodes. Common areas of extranodal involvement may include bone, gastrointestinal tract, and skin.

Splenic involvement in lymphoma is also common. It is usually evidenced by enlargement of the spleen (splenomegaly). Splenic or other extranodal involvement is most often detected by imaging techniques or pathological findings.

Specify if extranodal or splenic involvement was identified at the last evaluation.

Questions 287 – 288: Specify site(s) of involvement (check all that apply)

Specify all sites with known lymphomatous involvement at the last evaluation. Clarifications on some of the available option values are found below:

• Adrenal: The adrenals gland are small glands that sit on the top of each kidney and product hormones including sex hormones and cortisol. Select this option if there was lymphomatous involvement of or derived from the adrenal glands or their secretions.
• Cerebrospinal fluid (CSF): A clear, colorless body fluid found in the brain and spinal cord that is produced by specialized ependymal cells.
• Epidural space: The epidural space is an anatomic space that is the outermost part of the spinal canal. The epidural space contains lymphatics, spinal nerve roots, loose fatty tissue, small arteries, and a network of internal vertebral venous plexuses.
• Gastrointestinal (GI) tract: Any of the organs that food and liquids travel through when they are swallowed, digested, absorbed, and leave the body as feces. These organs include the mouth, pharynx, esophagus, stomach, small intestine, large intestine, rectum, and anus.
• Pericardium: Of or pertaining to the membrane enclosing the heart that consists of an outer fibrous later and an inner double layer of serous membrane.
• Pleura: The delicate serous membrane that lines each half of the thorax of mammals and is folded back over the surface of the lung of the same side. The function of the pleura is to allow optimal expansion and contraction of the lungs during breathing.
• Skin: Of or pertaining to the outer or surrounding layer of the skin (epidermis).
• Spleen: Of or pertaining to the abdominal organ involved in the product and removal of blood cells.
  

If an involved site was documented but is not listed as an option, check Other site and report all other sites of lymphomatous involvement.

Section Updates:

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