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NCT01556243

Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer

Version 29 to 30 · Alliance for Clinical Trials in Oncology

Patch inspector

Version 29 to 30

28 operations 5 path groups ctgov_internal_history
ClinicalTrials.gov
Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip the pipeline's suppression passes); the authoritative classification is the stored event record.
Plain-language summary

Manual review pending.

Rules fired
other_adverse_event_modification
Value signals
[
  {
    "paths": [
      "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
      "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
      "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame"
    ],
    "signal": "results_reconciliation_outcome_suppression",
    "category": "results_reconciliation",
    "severity": "low"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:59:36+00
Raw hash
9976e0c4e28b09a7e2c537db6b899377f365ef99d37d03a35ced074c8ecc4820
Payload
Source URL
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 3 ops
replace /protocolSection/outcomesModule/secondaryOutcomes/1/measure
Triage: High
Secondary Outcome Change Operation 4
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Type and Severity of Adverse Effects of Breast-conserving Surgery and Radiation as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
After
Severity of Adverse Effects
replace /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame
Triage: High
Secondary Outcome Change Operation 5
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Up to 30 days post-treatment
After
17 monhts
add /protocolSection/outcomesModule/secondaryOutcomes/1/description
Triage: High
Secondary Outcome Change Operation 6
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
Severity of adverse effects of breast-conserving surgery and radiation as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be reported as the percentage of patients that experienced a grade 3 or higher adverse event.
Adverse events and safety Posted serious or other adverse event data. Triage: Medium 5 ops
replace /resultsSection/adverseEventsModule/otherEvents/6/organSystem
Triage: Medium
Other Adverse Event Modification Operation 24
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
General disorders
After
General disorders and administration site conditions
replace /resultsSection/adverseEventsModule/otherEvents/7/organSystem
Triage: Medium
Other Adverse Event Modification Operation 25
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
General disorders
After
General disorders and administration site conditions
replace /resultsSection/adverseEventsModule/otherEvents/8/organSystem
Triage: Medium
Other Adverse Event Modification Operation 26
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
General disorders
After
General disorders and administration site conditions
replace /resultsSection/adverseEventsModule/otherEvents/9/organSystem
Triage: Medium
Other Adverse Event Modification Operation 27
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
General disorders
After
General disorders and administration site conditions
replace /resultsSection/adverseEventsModule/otherEvents/10/organSystem
Triage: Medium
Other Adverse Event Modification Operation 28
Matched rules
  • other_adverse_event_modification Modification of other adverse event result data is medium review priority.
Before
General disorders
After
General disorders and administration site conditions
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 7 ops
replace /protocolSection/contactsLocationsModule/locations/43/city
Triage: Uncategorized
Uncategorized Operation 7
Before
Coeur d'Alene
After
Couer D'Alene
remove /protocolSection/contactsLocationsModule/locations/43/geoPoint
Triage: Uncategorized
Uncategorized Operation 8
Before
{
  "lat": 47.67768,
  "lon": -116.78047
}
replace /protocolSection/contactsLocationsModule/locations/172/city
Triage: Uncategorized
Uncategorized Operation 9
Before
Cape Girardeau
After
Cape Giradeau
remove /protocolSection/contactsLocationsModule/locations/172/geoPoint
Triage: Uncategorized
Uncategorized Operation 10
Before
{
  "lat": 37.30588,
  "lon": -89.51815
}
replace /protocolSection/contactsLocationsModule/locations/237/city
Triage: Uncategorized
Uncategorized Operation 11
Before
Harrison
After
East White Plains
replace /protocolSection/contactsLocationsModule/locations/237/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 12
Before
40.96899
After
41.03899
replace /protocolSection/contactsLocationsModule/locations/237/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 13
Before
-73.71263
After
-73.74763
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 3 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2023-11
After
2026-05
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2023-11-07
After
2026-05-19
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 3
Before
2023-11-30
After
2026-06-12
Results outcome measures Posted result outcome measures and result-level endpoint data. Triage: Uncategorized 10 ops
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/title
Triage: Uncategorized
Uncategorized Operation 14
Before
Type and Severity of Adverse Effects of Breast-conserving Surgery and Radiation as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
After
Severity of Adverse Effects
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reportingStatus
Triage: Uncategorized
Uncategorized Operation 15
Before
NOT_POSTED
After
POSTED
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/timeFrame
Triage: Uncategorized
Uncategorized Operation 16
Before
Up to 30 days post-treatment
After
17 monhts
remove /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denomUnitsSelected
Triage: Uncategorized
Uncategorized Operation 17
Before
Participants
add /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description
Triage: Uncategorized
Uncategorized Operation 18
After
Severity of adverse effects of breast-conserving surgery and radiation as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be reported as the percentage of patients that experienced a grade 3 or higher adverse event.
add /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/paramType
Triage: Uncategorized
Uncategorized Operation 19
After
NUMBER
add /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/unitOfMeasure
Triage: Uncategorized
Uncategorized Operation 20
After
percentage of patients
add /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups
Triage: Uncategorized
Uncategorized Operation 21
After
[
  {
    "id": "OG000",
    "title": "Breast Conservation Surgery and Radiation Therapy",
    "description": "Patients undergo breast conserving surgery.\nPatients receive adjuvant chemotherapy at the physician's discretion.\nPatients receiving chemotherapy will start treatment within 12 weeks following surgery.\nPatients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy.\nPatients receive endocrine therapy at the physician's discretion.\nPatient observation will occur every 6 months until 5 years after the end of radiation therapy."
  }
]
add /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denoms
Triage: Uncategorized
Uncategorized Operation 22
After
[
  {
    "units": "Participants",
    "counts": [
      {
        "value": "270",
        "groupId": "OG000"
      }
    ]
  }
]
add /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes
Triage: Uncategorized
Uncategorized Operation 23
After
[
  {
    "categories": [
      {
        "measurements": [
          {
            "value": "4.8",
            "groupId": "OG000"
          }
        ]
      }
    ]
  }
]
Raw JSON Patch
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2026-05"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2026-05-19"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2026-06-12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
    "value": "Severity of Adverse Effects"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "value": "17 monhts"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
    "value": "Severity of adverse effects of breast-conserving surgery and radiation as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be reported as the percentage of patients that experienced a grade 3 or higher adverse event."
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/43/city",
    "value": "Couer D'Alene"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/43/geoPoint"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/172/city",
    "value": "Cape Giradeau"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/172/geoPoint"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/237/city",
    "value": "East White Plains"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/237/geoPoint/lat",
    "value": 41.03899
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/237/geoPoint/lon",
    "value": -73.74763
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/title",
    "value": "Severity of Adverse Effects"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reportingStatus",
    "value": "POSTED"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/timeFrame",
    "value": "17 monhts"
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denomUnitsSelected"
  },
  {
    "op": "add",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/description",
    "value": "Severity of adverse effects of breast-conserving surgery and radiation as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be reported as the percentage of patients that experienced a grade 3 or higher adverse event."
  },
  {
    "op": "add",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/paramType",
    "value": "NUMBER"
  },
  {
    "op": "add",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/unitOfMeasure",
    "value": "percentage of patients"
  },
  {
    "op": "add",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups",
    "value": [
      {
        "id": "OG000",
        "title": "Breast Conservation Surgery and Radiation Therapy",
        "description": "Patients undergo breast conserving surgery.\nPatients receive adjuvant chemotherapy at the physician's discretion.\nPatients receiving chemotherapy will start treatment within 12 weeks following surgery.\nPatients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy.\nPatients receive endocrine therapy at the physician's discretion.\nPatient observation will occur every 6 months until 5 years after the end of radiation therapy."
      }
    ]
  },
  {
    "op": "add",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/denoms",
    "value": [
      {
        "units": "Participants",
        "counts": [
          {
            "value": "270",
            "groupId": "OG000"
          }
        ]
      }
    ]
  },
  {
    "op": "add",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/classes",
    "value": [
      {
        "categories": [
          {
            "measurements": [
              {
                "value": "4.8",
                "groupId": "OG000"
              }
            ]
          }
        ]
      }
    ]
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/6/organSystem",
    "value": "General disorders and administration site conditions"
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/7/organSystem",
    "value": "General disorders and administration site conditions"
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/8/organSystem",
    "value": "General disorders and administration site conditions"
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/9/organSystem",
    "value": "General disorders and administration site conditions"
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/otherEvents/10/organSystem",
    "value": "General disorders and administration site conditions"
  }
]