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NCT04283773 · BASELINE

Baseline characteristics

Immunohistochemical Evaluation of Protein P16 Expression in Ovarian Germ Cell Tumors. · Source last updated 2021-09-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      22
    2. group Id
      BG001
      value
      20
    3. group Id
      BG002
      value
      20
    4. group Id
      BG003
      value
      62
    units
    Participants
groups
  1. description
    22 cases of malignant ovarian germ cell tumors ; include Dysgerminoma , yolk sac tumor and immature teratomas will be treated by anti P16 antibody . p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267): Treatment of slides that cut from paraffin embedded blocks related to groups by immunohistochemical method by p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267).
    id
    BG000
    title
    Malignant Ovarian Germ Cell Tumors ( MOGCTs).
  2. description
    20 cases of mature teratomas will be treated by anti P16 antibody .
    id
    BG001
    title
    Mature Cystic Teratomas.
  3. description
    20cases of normally apparent ovaries will be treated by anti P16 antibody .
    id
    BG002
    title
    Normally Apparent Ovaries.
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          12
          upper Limit
          23
          value
          16.5
        2. group Id
          BG001
          lower Limit
          14
          upper Limit
          50
          value
          31.5
        3. group Id
          BG002
          lower Limit
          42
          upper Limit
          64
          value
          50
        4. group Id
          BG003
          lower Limit
          12
          upper Limit
          64
          value
          30
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          62
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          62
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          62
      title
      Egypt
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          8
          value
          7
        2. group Id
          BG001
          lower Limit
          0
          upper Limit
          6
          value
          4
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          4
          value
          0
        4. group Id
          BG003
          lower Limit
          0
          upper Limit
          8
          value
          6
    description
    Percentage of positive cells and the location of positive signals (nuclear or cytoplasmic) visually estimated for of lesions. German Semi-quantitative scoring system is used to evaluate P16 expression. A score according to the intensity of staining (no staining = 0, weak = 1, moderate = 2, strong= 3) And the extent of stained cells (0% = 0, 1-10% = 1, 11-50% =2, 51-80% = 3, 81-100% = 4). The final score will be determined by multiplying the intensity scores with the extent of positivity scores of stained cells, with the minimum score of 0 and a maximum score of 12.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    P16 cytoplasmic expression
    unit Of Measure
    units on a scale
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          8
          value
          6
        2. group Id
          BG001
          lower Limit
          0
          upper Limit
          5
          value
          4
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          3
          value
          0
        4. group Id
          BG003
          lower Limit
          0
          upper Limit
          8
          value
          4
    description
    Percentage of positive cells and the location of positive signals (nuclear or cytoplasmic) visually estimated for of lesions. German Semi-quantitative scoring system is used to evaluate P16 expression. A score according to the intensity of staining (no staining = 0, weak = 1, moderate = 2, strong= 3) And the extent of stained cells (0% = 0, 1-10% = 1, 11-50% =2, 51-80% = 3, 81-100% = 4). The final score will be determined by multiplying the intensity scores with the extent of positivity scores of stained cells, with the minimum score of 0 and a maximum score of 12.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    P16 nuclear expression
    unit Of Measure
    units on a scale
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      22
    2. group Id
      BG001
      value
      20
    3. group Id
      BG002
      value
      20
    4. group Id
      BG003
      value
      62
    units
    Participants
groups
  1. description
    22 cases of malignant ovarian germ cell tumors ; include Dysgerminoma , yolk sac tumor and immature teratomas will be treated by anti P16 antibody . p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267): Treatment of slides that cut from paraffin embedded blocks related to groups by immunohistochemical method by p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267).
    id
    BG000
    title
    Malignant Ovarian Germ Cell Tumors ( MOGCTs).
  2. description
    20 cases of mature teratomas will be treated by anti P16 antibody .
    id
    BG001
    title
    Mature Cystic Teratomas.
  3. description
    20cases of normally apparent ovaries will be treated by anti P16 antibody .
    id
    BG002
    title
    Normally Apparent Ovaries.
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          12
          upper Limit
          23
          value
          16.5
        2. group Id
          BG001
          lower Limit
          14
          upper Limit
          50
          value
          31.5
        3. group Id
          BG002
          lower Limit
          42
          upper Limit
          64
          value
          50
        4. group Id
          BG003
          lower Limit
          12
          upper Limit
          64
          value
          30
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          62
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          62
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          62
      title
      Egypt
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          8
          value
          7
        2. group Id
          BG001
          lower Limit
          0
          upper Limit
          6
          value
          4
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          4
          value
          0
        4. group Id
          BG003
          lower Limit
          0
          upper Limit
          8
          value
          6
    description
    Percentage of positive cells and the location of positive signals (nuclear or cytoplasmic) visually estimated for of lesions. German Semi-quantitative scoring system is used to evaluate P16 expression. A score according to the intensity of staining (no staining = 0, weak = 1, moderate = 2, strong= 3) And the extent of stained cells (0% = 0, 1-10% = 1, 11-50% =2, 51-80% = 3, 81-100% = 4). The final score will be determined by multiplying the intensity scores with the extent of positivity scores of stained cells, with the minimum score of 0 and a maximum score of 12.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    P16 cytoplasmic expression
    unit Of Measure
    units on a scale
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          8
          value
          6
        2. group Id
          BG001
          lower Limit
          0
          upper Limit
          5
          value
          4
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          3
          value
          0
        4. group Id
          BG003
          lower Limit
          0
          upper Limit
          8
          value
          4
    description
    Percentage of positive cells and the location of positive signals (nuclear or cytoplasmic) visually estimated for of lesions. German Semi-quantitative scoring system is used to evaluate P16 expression. A score according to the intensity of staining (no staining = 0, weak = 1, moderate = 2, strong= 3) And the extent of stained cells (0% = 0, 1-10% = 1, 11-50% =2, 51-80% = 3, 81-100% = 4). The final score will be determined by multiplying the intensity scores with the extent of positivity scores of stained cells, with the minimum score of 0 and a maximum score of 12.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    P16 nuclear expression
    unit Of Measure
    units on a scale

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Preserved source evidence · Not medical advice