Donor Clinical Data Guidelines

Overview

This guide provides information on how to submit donor clinical data and how to interpret the validation rules/checks.

Field Definition Terms
donor_vital_status Donor's last known vital status.
  1. alive
  2. deceased
disease_status_last_followup Donor's last known disease status.
  1. complete remission
  2. partial remission
  3. progression
  4. relapse
  5. stable
  6. no evidence of disease
donor_relapse_interval If the donor was clinically disease free following primary treatment, and then relapse or progression (for liquid tumours) occurred afterwards, then "donor_relapse_interval" is the length of the disease free interval (in days).
donor_survival_time How long has the donor survived since primary diagnosis, in days. If source data was collected in months, use a multiplier value of '30.44' to convert values to days when preparing your submission.
donor_interval_of_last_followup Interval from the primary diagnosis date to the last followup date, in days. ICGC requests that patients be followed up every 6 months while alive. If source data was collected in months, use a multiplier value of '30.44' to convert values to days when preparing your submission.
donor_primary_treatment_interval Interval between primary diagnosis and primary treatment, in days.

Summary of Donor Clinical Field requirements:

This table summarizes the required fields (for data completeness), and describes the rules which ensure the clinical data is correct


disease_status_last_followup

complete remission

partial remission

stable

NED (no evidence of disease)

progression

relapse



donor_vital_status

alive

donor_relapse_interval =

donor_survival_time =

donor_interval_of_last_followup =

Checks:

If data provided for "donor_survival_time" and "donor_interval_of_last_followup":

    • donor_survival_time == donor_interval_of_last_followup
  • donor_relapse_interval =

    donor_survival_time =

    donor_interval_of_last_followup =

    Checks:

    • donor_relapse_interval <= donor_interval_of_last_followup
  • If data provided for "donor_survival_time":

    • donor_survival_time == donor_interval_of_last_followup
  • deceased

    donor_relapse_interval =

    donor_survival_time =

    donor_interval_of_last_followup =

    donor_relapse_interval =

    donor_survival_time =

    donor_interval_of_last_followup =

    Checks:

    • donor_relapse_interval <= donor_survival_time
  • Clinical Data Events and Time Relationship:

    This diagram summarizes how the different donor clinical events relate to time.

    If the patient is alive, the "donor_survival_time" should be equal to the "donor_interval_of_last_followup" (124 days)

    However, if the the patient is deceased, the "donor_survival_time" (163 days) should be less than (or equal) to the "donor_interval_of_last_followup" (175 days)

    Description of Script Restrictions for Donor Clinical Fields:

    1.

    Field: "donor_interval_of_last_followup"

    Description:

    If the disease status at last followup was progression or relapse:

      • "donor_interval_of_last_followup" field is required

    2.

    Field: "donor_survival_time"

    Description:

    When donor is deceased:

    • The field "donor_survival_time" is required.

    When donor is alive:

    • If "donor_survival_time" and "donor_interval_of_last_followup" have values, "donor_survival_time" must equal "donor_interval_of_last_followup"

    3.

    Field: "donor_relapse_interval"

    Description:

    If the donor's disease status at last followup was progression or relapse:

    • The field "donor_relapse_interval" is required.
    • If the donor is alive:
      • "donor_relapse_interval" should be less than or equal to "donor_interval_of_last_followup"
    • If donor is deceased:
      • "donor_relapse_interval" should be less then or equal to "donor_survival_time".

    4.

    Field: "donor_primary_treatment_interval"

    Description:

    The donor_primary_treatment_interval should be less than or equal to donor_survival_time

    If the patient's disease status at last followup was progression or relapse:

    If the patient is alive:

    • The combination of the donor_primary_treatment_interval and donor_relapse_interval should be less than or equal to the donor's interval of last followup.

    If the patient is deceased:

    • The combination of the donor_primary_treatment_interval and donor_relapse_interval should be less than or equal to the donor's survival time

    5.

    Field: "donor_age_at_diagnosis"

    Description:

    • If the donor is older than 90 years, default value of 90 should be used.
    • The donor's age at diagnosis should be less than or equal to the donor's age at enrolment

    6.

    Field: "donor_age_at_enrollment"

    Description:

    • If the donor is older than 90 years, default value of 90 should be used.
    • The donor's age at enrolment should be less than or equal to the donor's age at last_followup