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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 March 2022 |
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Main ID: |
NCT03053310 |
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Date of registration:
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03/02/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Value of Geriatric Screening to Predict Postoperative Morbidity for Head and Neck Cancer
GEROP |
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Scientific title:
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Determination of the Value of Geriatric Screening to Predict Postoperative Morbidity in an Older Head and Neck Cancer Population (GEROP) |
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Date of first enrolment:
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January 25, 2017 |
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Target sample size:
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94 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03053310 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Johan Abeloos, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AZ Sint-Jan Brugge-Oostende AV |
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Name:
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Araceli Diez-Fraile, PhD |
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Address:
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Telephone:
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Email:
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araceli.diez-fraile@azsintjan.be |
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Affiliation:
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Name:
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Araceli Diez-Fraile, Phd |
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Address:
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Telephone:
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0032(0)50459660 |
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Email:
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araceli.diez-fraile@azsintjan.be |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- - Patients aged 70 years or older at time of enrolment
- Both female and male patients
- Patients that are Dutch or French-speaking
- Patients with a histologically confirmed malignant tumour in the head and neck region,
in specific oral cavity, larynx, and pharynx ('head and neck cancer', defined
according to the NCCN guidelines)
- Patients undergoing surgery for a solid head and neck cancer tumour under general
anaesthesia. Preoperative data from patients considered ineligible for surgery, will
also be registered for scientific purposes
- Patients undergoing surgery and follow-up care at the division of maxillofacial
surgery or Department of Otorhinolaryngology, Head and Neck Surgery
Exclusion Criteria:
- - Patients not eligible according to the abovementioned criteria
- Patients with a spinocellular carcinoma of the skin
- Patients with distant metastases (stage IVc)
- Patients with another non-cured cancer, except for a squamous or basal cell carcinoma
of the skin
- Patients arriving at the emergency department for urgent surgical intervention
- Patients diagnosed with severe dementia, according to the DSM IV or MMSE =18, or
diagnosed psychiatric problems impeding proper preoperative assessment
Age minimum:
70 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Head and Neck
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Primary Outcome(s)
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30-day postoperative comorbidity
[Time Frame: 30 days postoperative]
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Secondary Outcome(s)
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quality of life, as measured with EORTC questionnaire
[Time Frame: 30 days, 6 months and 12 months postoperative]
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percentage of patients with major postoperative complications (grade >=3), Graded According to NCI CTCAE Version 4.0
[Time Frame: 30 days postoperative]
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percentage of patients not considered eligible for HNCA surgery, based on geriatric consult and/or MOC consult
[Time Frame: prior to surgery, at time of multidisciplinary oncology consult]
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vulnerability percentage of patients undergoing HNCA surgery, based on geriatric consult
[Time Frame: at time of surgery]
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Secondary ID(s)
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B049201629484
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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