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NCT01147016

Targeted T Cells After Neoadjuvant Chemotherapy in Treating Women With Stage II or III Breast Cancer Undergoing Surgery

Version 4 to 5 · Barbara Ann Karmanos Cancer Institute

Patch inspector

Version 4 to 5

21 operations 6 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
arms_or_interventions_changedesign_info_changeprimary_outcome_any_changesecondary_outcome_any_change
Value signals

None recorded.

Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:13:28+00
Raw hash
59d096a3386f49598785bddbb370f5365993195f13c4420157fb15597c7eda9a
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 2 ops
add /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
Triage: Critical
Primary Outcome Change Operation 16
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
After
Every 8 weeks or as indicated
add /protocolSection/outcomesModule/primaryOutcomes/1/timeFrame
Triage: Critical
Primary Outcome Change Operation 17
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
After
Every 8 weeks or as indicated
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 9 ops
add /protocolSection/designModule/designInfo/allocation
Triage: High
Design Change Operation 7
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
After
NA
add /protocolSection/designModule/designInfo/interventionModel
Triage: High
Design Change Operation 8
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
After
SINGLE_GROUP
add /protocolSection/armsInterventionsModule/interventions/0/description
Triage: High
Arm Intervention Change Operation 9
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Total of 4 of the T cell infusions intravenously over a period of 1 month.
add /protocolSection/armsInterventionsModule/interventions/1/description
Triage: High
Arm Intervention Change Operation 10
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
As prescribed by physician, standard of care.
add /protocolSection/armsInterventionsModule/interventions/2/description
Triage: High
Arm Intervention Change Operation 11
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
As prescribed by physician, standard of care.
add /protocolSection/armsInterventionsModule/interventions/3/description
Triage: High
Arm Intervention Change Operation 12
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
As prescribed by physician, standard of care.
add /protocolSection/armsInterventionsModule/interventions/4/description
Triage: High
Arm Intervention Change Operation 13
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Immune studies will be done pre-immunotherapy, prior to the third infusion of activated T-cells, at the time of surgery, and 1 month after immunotherapy.
If there are positive findings, additional optional studies will be done at 3, 6, and 12 months, if the immune studies show changes worthy of follow-up studies.
add /protocolSection/armsInterventionsModule/interventions/5/description
Triage: High
Arm Intervention Change Operation 14
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
As prescribed by physician, standard of care.
add /protocolSection/armsInterventionsModule/interventions/6/description
Triage: High
Arm Intervention Change Operation 15
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
As recommended by physician, post immunutherapy.
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 1 ops
add /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame
Triage: High
Secondary Outcome Change Operation 18
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
Every 3 months for the first year, and then every 6 months for one more year.
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 3 ops
remove /protocolSection/contactsLocationsModule/overallOfficials/0
Triage: Uncategorized
Uncategorized Operation 19
Before
{
  "name": "Amy Kranitz",
  "affiliation": "Barbara Ann Karmanos Cancer Institute"
}
replace /protocolSection/contactsLocationsModule/locations/0/contacts/0/phone
Triage: Uncategorized
Uncategorized Operation 20
Before
313-576-9363
After
313-576-8914
remove /protocolSection/contactsLocationsModule/locations/1
Triage: Uncategorized
Uncategorized Operation 21
Before
{
  "zip": "48235",
  "city": "Detroit",
  "state": "Michigan",
  "status": "RECRUITING",
  "country": "United States",
  "contacts": [
    {
      "name": "Zeina Nahleh",
      "role": "CONTACT",
      "phone": "313-576-8914"
    }
  ],
  "facility": "Sinai-Grace Hospital",
  "geoPoint": {
    "lat": 42.33143,
    "lon": -83.04575
  }
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 3 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 4
Before
2010-07
After
2010-10
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 5
Before
2010-09-23
After
2010-10-25
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 6
Before
2010-09-24
After
2010-10-26
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 3 ops
add /protocolSection/identificationModule/secondaryIdInfos/0
Triage: Uncategorized
Uncategorized Operation 1
After
{
  "id": "P30CA022453",
  "link": "https://reporter.nih.gov/quickSearch/P30CA022453",
  "type": "NIH"
}
replace /protocolSection/identificationModule/organization/fullName
Triage: Uncategorized
Uncategorized Operation 2
Before
National Cancer Institute (NCI)
After
Barbara Ann Karmanos Cancer Institute
replace /protocolSection/identificationModule/organization/class
Triage: Uncategorized
Uncategorized Operation 3
Before
NIH
After
OTHER
Raw JSON Patch 
[
  {
    "op": "add",
    "path": "/protocolSection/identificationModule/secondaryIdInfos/0",
    "value": {
      "id": "P30CA022453",
      "link": "https://reporter.nih.gov/quickSearch/P30CA022453",
      "type": "NIH"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/organization/fullName",
    "value": "Barbara Ann Karmanos Cancer Institute"
  },
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/organization/class",
    "value": "OTHER"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2010-10"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2010-10-25"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2010-10-26"
  },
  {
    "op": "add",
    "path": "/protocolSection/designModule/designInfo/allocation",
    "value": "NA"
  },
  {
    "op": "add",
    "path": "/protocolSection/designModule/designInfo/interventionModel",
    "value": "SINGLE_GROUP"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/description",
    "value": "Total of 4 of the T cell infusions intravenously over a period of 1 month."
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/description",
    "value": "As prescribed by physician, standard of care."
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/2/description",
    "value": "As prescribed by physician, standard of care."
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/3/description",
    "value": "As prescribed by physician, standard of care."
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/4/description",
    "value": "Immune studies will be done pre-immunotherapy, prior to the third infusion of activated T-cells, at the time of surgery, and 1 month after immunotherapy.\nIf there are positive findings, additional optional studies will be done at 3, 6, and 12 months, if the immune studies show changes worthy of follow-up studies."
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/5/description",
    "value": "As prescribed by physician, standard of care."
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/6/description",
    "value": "As recommended by physician, post immunutherapy."
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "Every 8 weeks or as indicated"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/1/timeFrame",
    "value": "Every 8 weeks or as indicated"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "value": "Every 3 months for the first year, and then every 6 months for one more year."
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/overallOfficials/0"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/0/contacts/0/phone",
    "value": "313-576-8914"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/1"
  }
]