Appendix3-GenericFollow-upFormVersion.pdf

Question # Data Element Label Entry Alternatives

12 months

24 months

36 months

48 months

60 months

2 Date of First Tumor Progression after Initial Treatment

Not Applicable

___ ___ (MM)

___ ___ (DD)

___ ___ ___ ___ (YYYY)

3 Date of Tumor Recurrence after

Initial Treatment

Not Applicable

___ ___ (MM)

___ ___ (DD)

___ ___ ___ ___ (YYYY)

Follow-up Interval

3.3 Year Numeric value to represent the year of an individual's tumor recurrence after initial treatment. (2897008)

Numeric value to represent the month of tumor progression in an individual after initial treatment. (2897014)

2.3 Year Numeric value to represent the year of tumor progression in an individual after initial treatment. (2897018)

3.1 Month Numeric value to represent the month of an individual's tumor recurrence after initial treatment. (2896991)

3.2 Day Numeric value to represent the day of an individual's tumor recurrence after initial treatment. (2897006)

The Cancer Genome Atlas (TCGA)

Generic Follow Up Form

2.2 Day Numeric value to represent the day of tumor progression in an individual after initial treatment. (2897016)

1. Completed By:

Tissue Source Site (TSS) Name: ________________________ ____________________________

TSS Identifier #: Date:

TSS Unique Patient # __________________________ caBIG Definition

2.1 Month

Complete follow-up form with the enrollment form for subjects whose procurement was obtained > 6 months ago. For subjects whose procurement occurred < 6 months ago, complete follow-up form at the appropriate time intervals specified below.

4 Date of Last Contact

___ ___ (MM)

___ ___ (DD)

___ ___ ___ ___ (YYYY)

___ ___ (MM)

___ ___ (DD)

___ ___ ___ ___ (YYYY)

Living

Deceased

Tumor Free

With Tumor

8 Date of Death Not Applicable

___ ___ (MM)

___ ___ (DD)

___ ___ ___ ___ (YYYY)

4.1 Month

4.2 Day

4.3 Year

Numeric value to represent the month of the last contact with a patient, family member, or caregiver. (2897020)

Numeric value to represent the day of the last contact with a patient, family member, or caregiver. (2897022)

Numeric value to represent the year of the last contact with a patient, family member, or caregiver. (2897024)

8.1 Month Numeric value to represent the month of the death of an individual.

(2897026)

8.2 Day Numeric value to represent the day of the death of an individual.

(2897028)

8.3 Year Numeric value to represent the year of the death of an individual.

(2897030)

5.3 Year Numeric value to represent the year of the last contact with a patient, family member, or caregiver. (2897024)

6 Vital Status

(at date of last contact)

Test summary level description of patient / participant survival status.

(2190384)

7 Tumor Status The state or condition of an individual’s neoplasm at a particular point in time. (2759550)

Date Last Known Alive

5.1 Month Numeric value to represent the month of the last contact with a patient, family member, or caregiver. (2897020)

5.2 Day Numeric value to represent the day of the last contact with a patient, family member, or caregiver. (2897022)

100 Normal, no complaints, no evidence of disease

90 Able to carry on normal activity; minor signs or symptoms of disease

80 Normal activity with effort;

some signs or symptoms of disease 70 Cares for self, unable to carry on normal activity or to do active work 60 Requires occasional assistance, but is able to care for most of his/her needs

50 Requires considerable assistance and frequent medical care

40 Disabled, requires special care and assistance 30 Severely disabled, hospitalization indicated.

Death not imminent 20 Very sick, hospitalization indicated. Death not imminent 10 Moribund, fatal processes progressing rapidly 0 Dead

Unknown

0 asymptomatic

1 symptomatic but fully ambulatory 2 symptomatic but in bed less than 50% of day

3 symptomatic, in bed more than 50% of the day

4 bed ridden

TCGA Follow Up Form

TSS Name:_________________ TSS Identifier #:

10 Performance Status Scale: Eastern

Cooperative Oncology Group

(ECOG)

The ECOG functional performance status of the patient/participant.

(88)

TSS Unique Patient # _____________________ caBIG Definition

9 Performance Status Scale:

Karnofsky Score

Score from the Karnofsky Performance status scale, representing the functional capabilities of a person. (2003853)

4 bed ridden

Unknown

Adjuvant

Post-adjuvant therapy

Other

Unknown

Yes

No

Unknown

___ ___ (MM)

___ ___ (DD)

___ ___ ___ ___ (YYYY)

Yes

No

Unknown

___ ___ (MM)

___ ___ (DD)

___ ___ ___ ___ (YYYY)

15.2 Day Numeric value to represent the day of a secondary surgical metastatic procedure for tumor recurrence or progression. (2897040)

13.3 Year Numeric value to represent the year of secondary locoregional surgery for tumor recurrence or progression. (2897036)

Secondary Surgery for tumor recurrence/progression:

Metastasis procedure

Numeric value to represent the year of a secondary surgical metastatic procedure for tumor recurrence or progression. (2897042)

For Adjuvant (first course ) Therapies (questions 16, 18, 20, 22, and 24), complete only if the patient was still undergoing treatment when the Enrollment Form was completed.

Indicator: The yes/no/unknown indicator that asks whether the recurrence was treated by surgery. (2199761)

Date of Secondary Surgery for Tumor Recurrence/Progression: Metastasis Procedure

15.1 Month Numeric value to represent the month of a secondary surgical metastatic procedure for tumor recurrence or progression. (2897038)

15.3 Year

11 Performance Status Scale: Timing A time point in reference to a patient's therapy in which a performance status assessment is conducted (2792763)

12 Secondary Surgery for tumor recurrence/ progression:

Locoregional procedure

Indicator: The yes/no/unknown indicator that asks whether the recurrence was treated by surgery. (2199761)

13.1 Month Numeric value to represent the month of secondary locoregional surgery for tumor recurrence or progression. (2897032)

13.2 Day Numeric value to represent the day of secondary locoregional surgery for tumor recurrence or progression. (2897034)

Date of Secondary Surgery for Tumor Recurrence/Progression: Locoregional

Procedure

Generic Follow-up Form Version 1.7 1.08.10 2 of 3

TCGA Follow Up Form

TSS Name:_________________ TSS Identifier #:

TSS Unique Patient # _____________________ caBIG Definition

9 Performance Status Scale: Score from the Karnofsky Performance status scale, representing the Yes

No

Unknown

Treatment Regimen Supplemental form for: Radiation)

Yes

No

Unknown

(If yes, complete Disease form for: Radiation)

Unknown form for: Chemotherapy)

Unknown

(If yes, complete Disease form for: Chemotherapy)

Unknown (If yes, complete Disease form for: Immunotherapy)

Unknown (If yes, complete Disease form for: Immunotherapy)

Adjuvant (Post-operative)

Immunotherapy

Indicator: The yes/No indicator related to whether a patient has received adjuvant postoperative Immunotherapy. (2756814)

22 Adjuvant (Post-operative)

Hormone Therapy (If

Indicator: The yes/no indicator related to whether adjuvant hormone therapy was administered following surgery. (2199669)

18 Adjuvant (Post-operative)

Chemotherapy

(If yes, complete Disease

Indicator: The Yes/no indicator related to initiation of adjuvant postoperative chemotherapy. (2756823)

21 Additional treatment of tumor recurrence or progression

Immunotherapy

Indicator: The yes/No indicator for the administration of additional immunotherapy to an individual after the recurrence or progression of disease. (2759828)

16 Adjuvant (Post-operative)

Irradiation therapy

(If yes, complete Disease

Indicator: The yes/no indicator related to initiation of therapeutic application of radiation to treat disease following surgery to remove tumor and associated malignant tissue. (2005312)

19 Additional treatment of tumor recurrence or progression

Chemotherapy

Indicator: The yes/no indicator related to the additional administration of chemotherapy after the return of a disease after a period of remission. (2650626)

17 Additional treatment of tumor recurrence or progression

Irradiation therapy

Indicator: the yes/no indicator related to the additional administration of the use of high-energy radiation from x-rays, gamma rays, neutrons, and other sources to kill cancer cells and shrink tumors after the return of a disease. (2650648)

No

Unknown form for: Hormonal Therapy)

Unknown

(If yes, complete Disease form for: Hormonal Therapy)

Unknown

Treatment Regimen Supplemental form for: Targeted Molecular

Therapy) Yes

No

Unknown

(If yes, complete Disease

Treatment Regimen Supplemental form for: Targeted Molecular

Therapy)

Print Name

Hormone Therapy (If yes, complete Disease therapy was administered following surgery. (2199669)

24 Adjuvant (Post-operative)

Targeted Molecular Therapy

(If yes, complete Disease

Text term to signify postoperative adjuvant cancer therapies which use drugs to act upon specific molecules, metabolic pathways or processes involved in carcinogenesis, tumor growth, or tumor spread.

(2785850)

Principal Investigator Signature

23 Additional treatment of tumor recurrence or progression

Hormone Therapy

Indicator: The yes/no indicator related to the additional administration of various treatment modalities that produce the desired therapeutic effect by means of change of hormone/hormones level after the return of a disease after a period of remission or new disease. (2650646)

25 Additional treatment of tumor recurrence or progression

Targeted Molecular Therapy

Text term to signify the treatment of an individual with recurrent or progressive disease with additional targeted therapy (2786150)

Comments:

Generic Follow-up Form Version 1.7 1.08.10 3 of 3