Q78-102: Disease Assessments at Last Evaluation

!Report the last evaluation documented prior to the start of the preparative regimen. The last assessment could be after the last line of therapy prior to collection / bridging therapy, or it could be as assessment completed prior to the last line of therapy prior to collection / bridging therapy

Question 78: Two largest dimensions of target lesion

The target lesion refers to a specific, measurable area that is chosen by the physician to monitor and assess the effectiveness of treatment.

Report the two largest dimensions of the target lesion, in centimeters, at the last evaluation prior to infusion. If the mass is given in three dimensions (for example: 3 cm x 5 cm x 4 cm), report the longest two dimensions.

Question 79: Date of imaging scan

Enter the date the imaging study (e.g., X-ray, CT scan, MRI scan) was performed at last evaluation prior to the preparative regimen / infusion to assess the recipient’s disease.

Question 80-82: Were metastases present?

Metastases can develop when cancer cells break away from the main tumor and enter the bloodstream or lymphatic system. This will be documented in a note, problem list, or imaging report.

If metastases were present at the last evaluation prior to the preparative regimen / infusion, select Yes specify the location(s) of metastases. Specify the location if Other location is selected.

*CIBMTR strongly encourages attaching the cytogenetic analysis report

Question 83: Were cytogenetics tested? (FISH or Karyotype)

Cytogenetics is the study of chromosomes. Cytogenetic assessment involves testing blood or bone marrow for the presence of known chromosomal abnormalities that reflect the recipient’s disease. Testing methods include conventional chromosome analysis (karyotyping) or fluorescence in situ hybridization (FISH). For more information about cytogenetic testing and terminology, see Appendix C, Cytogenetic Assessments.

Karyotyping is performed by culturing cells (growing cells under controlled conditions) until they reach the dividing phase. Techniques are then performed to visualize the chromosomes during cell division so that various bands and reconfigurations can be seen. Banding pattern differentiation and chromosomal reconfiguration demonstrate evidence of disease.

FISH is a sensitive technique that assesses a large number of cells. This technique uses special probes that recognize and bind to fragments of DNA. These probes are mixed with cells from the recipient’s blood or bone marrow. A fluorescent “tag” is then used to visualize the binding of the probe to the disease cells.

Indicate whether cytogenetic studies were obtained at the last evaluation prior to the preparative regimen / infusion. If cytogenetic studies were obtained at the last evaluation, select Yes. If cytogenetic studies were not obtained at this time point or it is not known whether chromosome studies were performed, indicate No or Unknown, respectively.

Questions 84-85: Were cytogenetics tested via FISH?

If FISH studies were performed at last evaluation prior to the preparative regimen / infusion, report Yes and indicate whether or not abnormalities were identified. If FISH studies were not performed at last evaluation, FISH samples were inadequate, or it is not known if performed, report No.

Report chromosomal microarrays / chromosomal genomic arrays as FISH assessments.

!International System for Human Cytogenetic Nomenclature (ISCN) Compatible String
The International System for Human Cytogenetic Nomenclature (ISCN) compatible string question is disabled and cannot be answered at this time.

Questions 86-88: Specify cytogenetic abnormalities identified via FISH

Report the International System for Human Cytogenetic Nomenclature (ISCN) compatible string if applicable.

Select all abnormalities identified via FISH at the last evaluation prior to the preparative regimen / infusion.

If an abnormality is detected but not listed as an option in, select Other abnormality and specify. If multiple other abnormalities were detected, report “see attached report” attach the final report(s) for any other abnormality detected. For further instructions on how to attach documents in FormsNet3^SM, refer to the Training Guide.

Question 89-90: Were cytogenetics tested via karyotyping?

If karyotyping was performed at the last evaluation prior to the preparative regimen / infusion, report Yes and indicate whether abnormalities were detected. If karyotyping performed, but there wasn’t any evaluable metaphase, report, No evaluable metaphases. If karyotyping was not performed at this time point or it is unknown, indicate No.

Questions 91-93: Specify cytogenetic abnormalities identified via karyotyping

Report the International System for Human Cytogenetic Nomenclature (ISCN) compatible string if applicable. Refer to Appendix C, Cytogenetics for more information on how to report using the ISCN functionality.

If an abnormality is detected but not listed as an option, select Other abnormality and specify the abnormality. If multiple other abnormalities were detected, report “see attached report” and attach the final report(s) for any other abnormality detected. For instructions on how to attach documents in FormsNet3^SM, refer to the Training Guide.

*CIBMTR strongly encourages attaching the molecular marker report

Question 94: Were tests for molecular markers performed? (e.g. PCR, NGS)

Molecular assessment involves testing blood or bone marrow for the presence of known molecular markers associated with the recipient’s disease. Molecular assessments are the most sensitive test for genetic abnormalities and involve amplifying regions of cellular DNA by polymerase chain reaction (PCR), typically using RNA to generate complementary DNA through reverse transcription (RT-PCR). The amplified DNA fragments are compared to a control, providing a method of quantifying log increase of genetic mutation transcripts. Each log increase is a 10-fold increase of gene transcript compared to control. Molecular methods are evolving and now include chromosomal microarray / chromosomal genomic array, Sanger sequencing, and next generation sequencing.

Indicate Yes or No if tests for molecular markers were performed at the last evaluation prior to the preparative regimen / infusion.

*Reporting Multiple Molecular Markers
Complete Specify the positive molecular marker, specify other molecular marker, amino acid change, and p. to report more than one gene mutation by adding an additional instance in FormsNet3^SM.

Questions 95-96: Specify the positive molecular marker

Specify the positive molecular marker. If a positive marker is detected, but not listed as an option, select Other molecular marker and specify.

If molecular markers were not identified, select None.

Question 97-98: Amino Acid change:

Amino acid changes can be described using standard mutation nomenclature. For CIBMTR reporting purposes, only amino acid changes based on protein-level sequences, beginning with the prefix “p.,” need to be reported.

For more information on nomenclature used for amino acid changes, visit the Human Genome Variation Society Sequence Variant Nomenclature Protein Recommendations.

Indicate if the amino acid change is Known or Unknown for the positive molecular marker reported in this instance. If Known, report the amino acid change.

Question 99: Grade/Differentiation

Grade/differentiation is a standardized way of measuring how developed and organized cancer cells are in a tissue or organ. A pathologist studies a biopsy sample to determine the grade, which is based on how abnormal the cells look. The grade indicates how aggressive the cancer is and how likely it is to grow and spread:

• Grade I: Well differentiated (low grade)
• Grade II: Moderately differentiated (intermediate grade)
• Grade III: Poorly differentiated (high grade)
• Grade IV: Undifferentiated (high grade)
• Unknown

Report the grade/differentiation at the last evaluation prior to the preparative regimen / infusion. Grading can be found the path report.
Source: https://www.cancer.gov/about-cancer/diagnosis-staging/diagnosis/tumor-grade

*TNM Classification¹
The TNM Classification is a system for classifying a malignancy. It is primarily used in solid tumors and can assist in prognostic cancer staging. A standard classification system improves provider communication and facilitates information sharing and research across populations. The system is based on assessing the tumor, regional lymph nodes, and distant metastasis, as detailed below.
Each solid tumor type has a version of TNM classification

Question 100: Solid tumor – (T) tumor

(T) tumor is used to describe the size of the primary tumor and its’ invasion into adjacent tissues. T0 indicates no evidence of tumor is present, while T1-T4 is used to identify the size and extension of the tumor, with progressive enlargement and invasiveness from T1 to T4.

T-values are assessed differently based on the involved anatomic structures.

• TX means there’s no information about the primary tumor, or it can’t be measured.
• T0 means there is no evidence of a primary tumor (it cannot be found).
• A number after the T (such as T1, T2, T3, or T4) might describe the tumor size and/or amount of spread into nearby structures. The higher the T number, the larger the tumor and/or the more it has grown into nearby tissues.
  

Report the classification of the (T) tumor at the last evaluation prior to the preparative regimen / infusion.

Question 101: Solid tumor – (N) lymph node

(N) lymph node is used to describe regional lymph node involvement of the tumor. Lymph nodes function as biological filters, as fluid from body tissues is absorbed into lymphatic capillaries and flows to the lymph nodes.

• NX means there’s no information about the nearby lymph nodes, or they can’t be assessed
• N0 indicates no regional nodal spread
• N1-N3 indicates some degree of nodal spread, with a progressively distal spread from N1 to N3

Report the classification of the (N) lymph node at the last evaluation prior to the preparative regimen / infusion.

Question 102: Solid tumor – (M) metastasis

(M) metastasis is used to identify the presence of distant metastases of the primary tumor.

• M0 means that no distant cancer spread has been found.
• M1 means that the cancer has been found to have spread to distant organs or tissues.

Report the classification of the (M) metastases at the last evaluation prior to the preparative regimen / infusion.

¹ Rosen RD, Sapra A. TNM Classification. [Updated 2023 Feb 13]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK553187/

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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CIBMTR® (Center for International Blood and Marrow Transplant Research) is a research collaboration between the Medical College of Wisconsin and NMDP.