Appendix E -The Cancer Genome Atlas Forms - GBM.PDF

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The Cancer Genome Atlas (TCGA)

Clinical Data Reporting Form - GBM

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Internal Use Only

Tissue Source Site (TSS) Name: ________________________

TSS Identifier #:

Tier 1 Clinical Data Definition: All of these elements (1-22) are required to “qualify” the tumor specimen for TCGA project.

1. Completed By:

2. Completed By:

Tier 1 Clinical Data (Page 1 of 3)

Tier # Data Element Label Entry Alternatives caBIG Definition

1: 01 TSS Unique Patient #

1: 02 Organ of Origin – GBM Brain

Lung

Ovary

Text term for originating or primary anatomic site of the disease/condition under investigation or review.

(2735776)

1: 03 Histological Type:

a. Untreated primary

(De Nova) GBM

b. Prior brain tissue diagnosis of lower grade Glioma

Yes

No

Text term to indicate whether or not a brain tumor is the first occurrence of Glioblastoma Multiforme, which forms from glial (supportive) tissue of the brain and grows quickly. (2753300)

Text term to signify if a person had an earlier diagnosis of glioma with a lower histologic grade than the current glioma grade. (2786111)

1:04 Gender

Male

Female

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)

1: 05 Date of Birth

Person's Birth date (2201154)

1: 06 Reserved for Future Use

1: 07 Tobacco smoking history indicator (Ovary-GBM: N/A)

N/A

Text indicator to represent a person’s tobacco smoking, the act of puffing and/or inhaling smoke from a lit tobacco cigarette, cigar, or pipe. (2436233)

1: 08 Date of initial pathologic diagnosis

The date this disease was first diagnosed. (58204)

1: 09 Neo-adjuvant (pre-operative) therapy

(If yes, this is an exclusion criterion)

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

1: 10 Date of Surgical Resection

The date of a surgical procedure. (2003986)

Date:

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TCGA Clinical Data Reporting Form - GBM

TSS Name:_________________ TSS Identifier #:

TSS Unique Patient # _____________________

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Internal Use Only

Tier 1 Clinical Data (Page 2 of 3)

Tier # Data Element Label Entry Alternatives caBIG Definition

1: 11 Tumor Stage (pathological)

GBM

N/A Text term to represent the name of the histologic category or classification of a brain tumor. (2467507)

1: 12 Tumor Grade: GBM

Numeric value to express the degree of abnormality of cancer cells, a measure of differentiation and aggressiveness. (2785839)

1: 13 Complete Excision (RO) Yes (RO)

No (R1)

Unknown

Term to signify the complete removal or excision by surgical means of the primary tumor, so that surgical margins are free of gross and microscopic tumor.

(2785845)

1: 14 Adjuvant (Post-Operative)

Irradiation therapy

Yes

No

Unknown

Yes/no indicator to ask if therapeutic application if radiation was initiated to treat disease following surgery to remove tumor and associated malignant tissue.

(2005312)

1: 15 Adjuvant (Post-Operative)

Chemotherapy

Yes

Unknown

Text term to indicate whether a patient has received adjuvant postoperative chemotherapy. (2756823)

1: 16 Adjuvant (Post-Operative)

Immunotherapy

Yes

Text term to indicate whether a patient has received adjuvant postoperative Immunotherapy. (2756814)

1: 17 Adjuvant (Post-Operative)

Hormonal Therapy

Yes

Yes/no/unknown indicator whether adjuvant hormone therapy was administered following surgery. (2199669)

1: 18 Adjuvant (Post-Operative)

“Targeted” Molecular

Therapy

Yes

No

Unknown

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)

1: 19 Date of first Recurrence after therapy

N/A =Tumor has not recurred at time of last clinical evaluation. (See 1:20)

The date related to the diagnosis or recognition of the presence and nature of the return of signs and symptoms of cancer after a period of improvement.(2663381)

1: 20 Date of Last Contact

(clinical evaluation)

The date of the last successful contact with the patient, family member, or caregiver to establish responses for

1:21 and 1:22 below. (2004147)

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TSS Name:_________________ TSS Identifier #:

TSS Unique Patient # _____________________

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Tier 1 Clinical Data (Page 3 of 3)

1: 21 Vital Status (date of last contact)

Living

Deceased

Test summary level description of patient / participant survival status. (2190384)

1: 22 Date of Death N/A

The actual date of a patients/participants death.

(2004152)

Comments:____________________________________________________________________________

Principal Investigator Signature Print Name M M D D Y Y

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The Cancer Genome Atlas (TCGA)

Clinical Data Reporting Form – GBM

Barcode

Internal Use Only

Tissue Source Site (TSS) Name: ________________________

TSS Identifier #:

TSS Unique Patient # __________________________

Tier 2 Clinical Data Definition: Desirable, but not manditory clinical information for clinical correlation analyses.

1. Completed By:

2. Completed By:

Tier 2 Clinical Data (Page 1 of 4)

Tier # Data Element Label Entry Alternatives caBIG Definition

2: 02 Anatomic Organ Sub-

Division

a. Brain

b. Lung

c. Ovary

Brain N/A

Lung R Upper Middle Lower

L Upper Lower

Ovary Right

Left

Bilateral

Unknown

Anatomic organ: Text term for originating of 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)

2: 08 Method of initial pathologic diagnosis

(check all that apply)

Cytology (e.g. peritoneal or pleural fluid)

Fine needle aspiration biopsy

Incision biopsy

Excisional biopsy

Tumor resection

Other method, specify:

Unknown

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

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

2: 14

Adjuvant

(Post-operative)

Irradiation therapy

(If yes, complete Disease Treatment

Regimen Supplemental form for:

Radiation)

Yes/no indicator to ask if therapeutic application of radiation was initiated to treat disease following surgery to remove tumor and associated malignant tissue.

(2005312)

2:15 Adjuvant (Post-operative)

Chemotherapy

Pharmaceutical Therapy)

Text term to indicate whether a patient has received adjuvant postoperative chemotherapy. (2756823)

2: 16 Adjuvant

(Post-operative)

Immunotherapy

Pharmaceutical Therapy)

Text term to indicate whether a patient has received adjuvant postoperative

Immunotherapy. (2756814)

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TSS Name:_________________ TSS Identifier #:

TSS Unique Patient # _____________________

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Internal Use Only

Tier 2 Clinical Data (Page 2 of 4)

Tier # Data Element Label Entry Alternatives caBIG Definition 2: 17 Adjuvant

(Post-operative)

Hormone therapy

Pharmaceutical Therapy)

Yes/no/unknown indicator whether adjuvant hormone therapy was administered following surgery.

(2199669

2: 18 Adjuvant

(Post-operative)

Targeted Molecular Therapy

Pharmaceutical Therapy)

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)

2: 00A Race

Ethnicity

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)

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

Hispanic or Latino (A person of Mexican, Puerto Rican, Cuban, Central or South American or other Spanish culture or origin, regardless of race)

Not reported (Not provided or available)

Unknown (Could not be determined or unsure)

The text for reporting information about race based on the Office of

Management and Budget (OMB) categories. (2192199)

The text for reporting information about ethnicity based on the Office of

Management and Budget (OMB) categories. (2192217)

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TSS Name:_________________ TSS Identifier #:

TSS Unique Patient # _____________________

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Internal Use Only

Tier 2 Clinical Data (Page 3 of 4)

Tier # Data Element Label Entry Alternatives caBIG Definition 2: 21 Vital Status

A. Living

B. Deceased

Living (cancer status)

Tumor Free

With Tumor

Unknown Tumor Status

Deceased (cancer status)

Tumor Free

With Tumor

Unknown Tumor Status

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

The state or condition of an individual’s neoplasm at a particular point in time.

(2759550)

2: 00B Performance Status Scale

(complete Karnofsky Score

Or

Eastern Cancer Oncology

Group)

Not Recorded

Karnofsky Score

100 asymptomatic

80-90 symptomatic but fully ambulatory

60-70 symptomatic but in bed less then

50% of day

40-50 symptomatic, in bed more than

50% of the day, but not bed ridden

20-30 bed ridden

Eastern Cancer Oncology Group

(ECOG)

0 asymptomatic

1 symptomatic but fully ambulatory

2 symptomatic but in bed less then

50% of day

3 symptomatic, in bed more than 50% of the day, but not bed ridden

4 bed ridden

Timing of score:

Preoperative

Pre-adjuvant therapy

Post-adjuvant therapy

Other

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

(2003853)

The ECOG functional performance status of the patient/participant.

(88)

2: 00C Secondary Surgery for tumor recurrence or progression

None

Loco-regional procedure:

Metastasis procedure:

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

(2199761)

Procedure: Name of the secondary surgical procedure performed for recurrent or progressive disease.

(2759612)

Date: Date of the secondary surgical procedure performed for recurrent or progressive disease. (2759616)

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TSS Name:_________________ TSS Identifier #:

TSS Unique Patient # _____________________

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Internal Use Only

Tier 2 Clinical Data (Page 4 of 4)

Tier # Data Element Label Entry Alternatives caBIG Definition 2: 00D Additional treatment of tumor recurrence/progression

Irradiation therapy

Radiation)

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)

2: 00E Additional treatment of tumor recurrence/progression

Chemotherapy

Pharmaceutical Therapy)

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

(2650626)

2: 00F Additional treatment of recurrence/progression

Immunotherapy

Pharmaceutical Therapy)

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

2: 00G Additional treatment of recurrence/progression

Hormone Therapy

Pharmaceutical 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)

2: 00H Additional treatment of recurrence/progression

Targeted molecular therapy

Pharmaceutical Therapy)

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

Comments:

Principal Investigator Signature Print Name M M D D Y Y