Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02007200 · OUTCOME

Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone

Soy Isoflavones in Preventing Head and Neck Cancer Recurrence in Patients With Stage I-IV Head and Neck Cancer Undergoing Surgery · Source last updated 2016-10-24

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

Measure
MEAN
Unit
Percent change
Interval / dispersion
Full Range
Time frame
From baseline to surgery, up to 42 days

What was measured

The change in methylation will be analyzed in parallel using a linear repeated measures model. The fixed effects will be time (pre-treatment versus post-treatment), current smoking status (yes or no), their interaction, and tissue type (tumor or not). Satterthwaite's adjustment to the degrees of freedom will be applied to account for heteroscedasticity. The differential effect of soy isoflavone on tumor and non-tumor tissues between smokers and non-smokers will be assessed using linear contrasts.

Analysis population: 55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.

Groups in this outcome

Treatment (Soy Isoflavones)

Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Treatment (Soy Isoflavones)39

Reported measurements

Source class 1
Values in Percent change · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Treatment (Soy Isoflavones)4.9Not reported-34.820.9Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.005
    statistical Method
    Linear Repeated Measures Model
    tested Non Inferiority
    false
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.005
    statistical Method
    Linear Repeated Measures Model
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -34.8
        upper Limit
        20.9
        value
        4.9
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    units
    Participants
description
The change in methylation will be analyzed in parallel using a linear repeated measures model. The fixed effects will be time (pre-treatment versus post-treatment), current smoking status (yes or no), their interaction, and tissue type (tumor or not). Satterthwaite's adjustment to the degrees of freedom will be applied to account for heteroscedasticity. The differential effect of soy isoflavone on tumor and non-tumor tissues between smokers and non-smokers will be assessed using linear contrasts.
dispersion Type
Full Range
groups
  1. description
    Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
    id
    OG000
    title
    Treatment (Soy Isoflavones)
param Type
MEAN
population Description
55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.
reporting Status
POSTED
time Frame
From baseline to surgery, up to 42 days
title
Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone
type
PRIMARY
unit Of Measure
Percent change

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice