Appendix3-GenericEnrollmentFormV1.7.pdf

Question # Data Element Label Entry Alternatives

To be specified

To be specified

Male

Female

2 Histological Type: Text term to represent the category of a neoplasm's histologic subtype. (2831122)

3 Anatomic Organ Sub-

Division

Date of Birth

4 Gender Text designations that identify gender. Gender is described as the assemblage of properties that distinguish people on the basis on their social roles. Explanatory

Comment 1: Identification of gender is based upon self-report and may come from a form, questionnaire, interview, etc. (2200604)

Organ of Origin To be specified Text term for originating or primary anatomic site of the disease/condition under investigation or review.

(2735776)

Detailed spatial description to provide the exact location of an anatomic site or location. (2008006)

Date:

Tissue Source Site (TSS) Name: ________________________

TSS Unique Patient # __________________________ caBIG Definition

Enrollment form to be completed upon qualification notice from the BCR. For subjects where tissue procurement occurred > 6 months ago, please also complete and submit a follow-up form at this time.

1. Completed By:

The Cancer Genome Atlas (TCGA)

TSS Identifier #:

GENERIC Enrollment Form

___ ___ (MM)

___ ___ (DD)

___ ___ ___ ___ (YYYY)

American Indian or Alaska Native (A person having origins in any of the original peoples of North and South America (including Central America), and who maintains tribal affiliation or community attachment)

Asian ( A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and

Vietnam)

White (A person having origins in any of the original peoples of Europe, the Middle East, or North

Africa)

Black or African American (A person having origins in any of the black racial groups of Africa.

Terms such as "Haitian" or "Negro" can be used in addition to "Black or African American.")

Native Hawaiian or other Pacific Islander ( A person having origins in any of the original peoples of

Hawaii, Guam, Samoa, or other Pacific Islands)

Not Reported (Not provided or available)

Unknown (Could not be determined or unsure)

5.1 Month Numeric value to represent the month in which an

individual was born. (2896950)

5.2 Day Numeric value to represent the day on which an individual was born. (2896952)

6 Race The text for reporting information about race based on the Office of Management and Budget (OMB) categories.

(2192199)

5.3 Year Numeric value to represent the calendar year in which an individual was born. (2896954)

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Not Reported (Not provided or available)

Unknown (Could not be determined or unsure)

Yes: please complete Prior Tumor Form

No

Unknown

___ ___ (MM)

___ ___ (DD)

___ ___ ___ ___ (YYYY)

Cytology

Fine needle aspiration biopsy

Incision biopsy

Excisional biopsy

Tumor resection

Other method, specify in below

Yes

(If yes, this is an exclusion criterion)

No

TCGA GENERIC Enrollment Form

TSS Name:_________________ TSS Identifier #:

TSS Unique Patient # _____________________

Surgical Resection Date

The yes/no indicator to ask whether any treatment was given to the patient prior to surgery. (64176)

Method: Text name of the procedure to secure the tissue used for the original pathologic diagnosis. (2757941)

9.2 Day

Other Method of Initial

Pathologic Diagnosis _______________________________

12 Neo-adjuvant (pre-operative) therapy

Method of initial pathologic diagnosis

Numeric value to represent the month of an individual's initial pathologic diagnosis of cancer. (2896956)

Numeric value to represent the day of an individual's initial pathologic diagnosis of cancer. (2896958)

9.3 Year Numeric value to represent the year of an individual's initial pathologic diagnosis of cancer. (2896960)

8 Has this patient at any time in their life had a prior diagnosis of a malignant neoplasm?

CDE To Be Determined

Date of Initial Pathologic Diagnosis

9.1 Month

7 Ethnicity Not Hispanic or Latino (A person not meeting the definition for Hispanic or Latino)

The text for reporting information about ethnicity based on the Office of Management and Budget (OMB) categories. (2192217) Hispanic or Latino (A person of Mexican, Puerto

Rican, Cuban, Central or South American or other caBIG Definition

Other method: Text to describe a method used to secure tissue for an original pathologic diagnosis that is different from the identified methods. (2757948)

___ ___ (MM)

___ ___ (DD)

___ ___ ___ ___ (YYYY)

Not Applicable - (for some tumors)

RX

R0

R1

R2

Not Applicable

TX

T0

Tis

T1

T1a

T1b

T2

T2a

T2b

T3

T4

Not Applicable

NX

N0

N1

N2

N3

Numeric value to represent the month of an individual's surgical resection procedure. (2896963)

13.2 Day Numeric value to represent the day of an individual's surgical resection procedure. (2896965)

Surgical Resection Date

13.1 Month

15 Pathologic Spread:

Primary Tumor (T)

Code for pathologic T (tumor) stage of cancer using the

AJCC TNM system of numbered categories for representation of data. (2008092)

CDE TBD

16 Pathologic Spread:

Regional Nodes (N)

Code for pathologic N (Nodal) stage of cancer using AJCC

TNM system of numbered categories for representation of data. (2008091)

13.3 Year Numeric value to represent the year of an individual's surgical resection procedure. (2896985)

14 Residual Tumor Text terms to describe the status of a tissue margin following surgical resection. (2608702)

Using the AJCC TNM system of numbered categories for representation of data.

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TCGA GENERIC Enrollment Form

TSS Name:_________________ TSS Identifier #:

TSS Unique Patient # _____________________

7 Ethnicity Not Hispanic or Latino (A person not meeting the The text for reporting information about ethnicity based caBIG Definition

MX

M0

M1

M1a

M1b

18 Tumor Stage To be specified

(pathological)

___ ___ (MM)

___ ___ (DD)

___ ___ ___ ___ (YYYY)

20.1 Month

___ ___ (MM)

20.2 Day

___ ___ (DD)

20.3 Year

___ ___ ___ ___ (YYYY)

Living

Deceased

Tumor Free

With Tumor

23 Date of Death Not Applicable

___ ___ (MM)

19.3 Year TBD

Vital Status

(at date of last contact)

TBD

CDE for AJCC TBD

23.2 Day Numeric value to represent the day of the death of an

23.1 Month Numeric value to represent the month of the death of an individual. (2897026)

Date Last Known Alive

TBD

TBD

TBD

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

19.1 Month TBD

19.2 Day TBD

Date of Last Contact

17 Distant Spread: Distant

Metastasis (M)

Code for pathologic M (Metastasis) stage of cancer using

AJCC TNM system of numbered categories for representation of data. (2008091)Absence or presence of distant metastasis as determined prior to treatment based on evidence of tumor in microscopic examination of distant lesions. (2183) TBD

___ ___ (DD)

___ ___ ___ ___ (YYYY)

24 Molecular Markers for tumor prognosis or responsiveness to treatment

Tumor Specific Categories (may not apply to all subtypes)

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. 20 Very sick, hospitalization

10 Moribund, fatal processes progressing rapidly

0 Dead

Unknown

25 Performance Status

Scale: Karnofsky Score

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

(2003853)

23.3 Year Numeric value to represent the year of the death of an individual. (2897030)

23.2 Day Numeric value to represent the day of the death of an individual. (2897028)

CDE To Be Determined

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TCGA GENERIC Enrollment Form

TSS Name:_________________ TSS Identifier #:

TSS Unique Patient # _____________________

7 Ethnicity Not Hispanic or Latino (A person not meeting the The text for reporting information about ethnicity based caBIG Definition

0 asymptomatic

1 symptomatic but fully ambulatory than 50% of day

3 symptomatic, in bed more than 50% of the day 4 bed ridden

Unknown

Preoperative

Pre-adjuvant therapy

Post-adjuvant therapy

Other

Unknown

Print Name

Did the subject receive any adjuvant (first course) therapies (chemotherapy, radiation therapy, immunotherapy, hormonal, or targeted molecular)? If yes, please complete appropriate supplemental form.

Principal Investigator Signature

Comments:

26 Performance Status

Scale: Eastern

Cooperative Oncology

Group (ECOG)

The ECOG functional performance status of the patient/participant. (88)

27 Performance Status

Scale: Timing

A time point in reference to a patient's therapy in which a performance status assessment is conducted (2792763)

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