ID

15156

Beschrijving

Comprehensive Patient Questionnaires in Predicting Complications in Older Patients With Gynecologic Cancer Undergoing Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT02315469

Link

https://clinicaltrials.gov/show/NCT02315469

Trefwoorden

  1. 19-05-16 19-05-16 -
  2. 20-09-21 20-09-21 -
Geüploaded op

19 mei 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Fallopian Tube Carcinoma NCT02315469

Eligibility Fallopian Tube Carcinoma NCT02315469

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with suspected ovarian, fallopian tube, primary peritoneal carcinomas or advanced stage papillary serous uterine carcinoma irrespective of performance status; this clinical determination is made by the treating physician
Beschrijving

Ovarian Carcinoma | Fallopian Tube Neoplasms | Primary Peritoneal Carcinoma | Papillary carcinoma of uterus Advanced phase | performance status

Datatype

boolean

Alias
UMLS CUI [1]
C0029925
UMLS CUI [2]
C0015558
UMLS CUI [3]
C1514428
UMLS CUI [4,1]
C0279764
UMLS CUI [4,2]
C0205179
UMLS CUI [5]
C1518965
patients must have signed an approved informed consent and authorization permitting release of personal health information
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
patients who can understand sufficiently to be able to respond to questions posed by the study instruments
Beschrijving

Comprehension | Able to respond to communication by others | Study Protocol

Datatype

boolean

Alias
UMLS CUI [1]
C0162340
UMLS CUI [2]
C0566155
UMLS CUI [3]
C2348563
patients and/or caregiver (durable power of attorney) can give consent and caregiver can assist with the responses to questionnaire
Beschrijving

Patients | Caregiver | Consent | Response Questionnaires

Datatype

boolean

Alias
UMLS CUI [1]
C0030705
UMLS CUI [2]
C0085537
UMLS CUI [3]
C1511481
UMLS CUI [4,1]
C2911692
UMLS CUI [4,2]
C0034394
note: it is the intent of this trial that all patients 70 years or older presenting to the participating physician/center be offered enrollment onto this study; eligible patients may enroll and subsequently receive neoadjuvant chemotherapy followed by interval surgery, primary cytoreductive surgery or no surgery at all
Beschrijving

Age | Neoadjuvant Therapy Chemotherapy Regimen | Operative Surgical Procedures Interval | Cytoreduction Surgical Procedures

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0392920
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C1272706
UMLS CUI [4]
C3850079
post-operative pathology will not exclude patients from this study
Beschrijving

Pathology Postoperative

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205469
UMLS CUI [1,2]
C0231287
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up
Beschrijving

Life circumstances Compliance behavior Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680082
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0439801
patients who would have planned surgery performed by the minimally invasive technique; institutions which perform cytoreductive surgery via the minimally invasive technique should not participate in this study; the minimally invasive surgery (mis) technique is also not considered standard technique for primary cytoreductive surgery for advanced stage ovarian, fallopian tube or peritoneal cancers
Beschrijving

Minimally Invasive Surgical Procedures | Cytoreductive surgery | Ovarian Carcinoma | Fallopian Tube Neoplasms | Malignant tumor of peritoneum | Advanced phase

Datatype

boolean

Alias
UMLS CUI [1]
C0282624
UMLS CUI [2]
C1112438
UMLS CUI [3]
C0029925
UMLS CUI [4]
C0015558
UMLS CUI [5]
C0153467
UMLS CUI [6]
C0205179
patients who receive chemotherapy treatment (for a gynecologic malignancy) prior to consideration of enrollment into this trial and taking the geriatric assessment will be excluded
Beschrijving

Chemotherapy Regimen | Malignant Neoplasms Gynecologic | Geriatric Assessment

Datatype

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0205480
UMLS CUI [3]
C0017463
patients who have a known pre-operative primary uterine cancer, confirmed by endometrial biopsy
Beschrijving

Uterine Cancer Preoperative | Endometrial biopsy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0153567
UMLS CUI [1,2]
C0445204
UMLS CUI [2]
C1510477

Similar models

Eligibility Fallopian Tube Carcinoma NCT02315469

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Ovarian Carcinoma | Fallopian Tube Neoplasms | Primary Peritoneal Carcinoma | Papillary carcinoma of uterus Advanced phase | performance status
Item
patients with suspected ovarian, fallopian tube, primary peritoneal carcinomas or advanced stage papillary serous uterine carcinoma irrespective of performance status; this clinical determination is made by the treating physician
boolean
C0029925 (UMLS CUI [1])
C0015558 (UMLS CUI [2])
C1514428 (UMLS CUI [3])
C0279764 (UMLS CUI [4,1])
C0205179 (UMLS CUI [4,2])
C1518965 (UMLS CUI [5])
Informed Consent
Item
patients must have signed an approved informed consent and authorization permitting release of personal health information
boolean
C0021430 (UMLS CUI [1])
Comprehension | Able to respond to communication by others | Study Protocol
Item
patients who can understand sufficiently to be able to respond to questions posed by the study instruments
boolean
C0162340 (UMLS CUI [1])
C0566155 (UMLS CUI [2])
C2348563 (UMLS CUI [3])
Patients | Caregiver | Consent | Response Questionnaires
Item
patients and/or caregiver (durable power of attorney) can give consent and caregiver can assist with the responses to questionnaire
boolean
C0030705 (UMLS CUI [1])
C0085537 (UMLS CUI [2])
C1511481 (UMLS CUI [3])
C2911692 (UMLS CUI [4,1])
C0034394 (UMLS CUI [4,2])
Age | Neoadjuvant Therapy Chemotherapy Regimen | Operative Surgical Procedures Interval | Cytoreduction Surgical Procedures
Item
note: it is the intent of this trial that all patients 70 years or older presenting to the participating physician/center be offered enrollment onto this study; eligible patients may enroll and subsequently receive neoadjuvant chemotherapy followed by interval surgery, primary cytoreductive surgery or no surgery at all
boolean
C0001779 (UMLS CUI [1])
C0600558 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C1272706 (UMLS CUI [3,2])
C3850079 (UMLS CUI [4])
Pathology Postoperative
Item
post-operative pathology will not exclude patients from this study
boolean
C0205469 (UMLS CUI [1,1])
C0231287 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Life circumstances Compliance behavior Limited
Item
patients whose circumstances at the time of study entry do not permit completion of the study or required follow-up
boolean
C0680082 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Minimally Invasive Surgical Procedures | Cytoreductive surgery | Ovarian Carcinoma | Fallopian Tube Neoplasms | Malignant tumor of peritoneum | Advanced phase
Item
patients who would have planned surgery performed by the minimally invasive technique; institutions which perform cytoreductive surgery via the minimally invasive technique should not participate in this study; the minimally invasive surgery (mis) technique is also not considered standard technique for primary cytoreductive surgery for advanced stage ovarian, fallopian tube or peritoneal cancers
boolean
C0282624 (UMLS CUI [1])
C1112438 (UMLS CUI [2])
C0029925 (UMLS CUI [3])
C0015558 (UMLS CUI [4])
C0153467 (UMLS CUI [5])
C0205179 (UMLS CUI [6])
Chemotherapy Regimen | Malignant Neoplasms Gynecologic | Geriatric Assessment
Item
patients who receive chemotherapy treatment (for a gynecologic malignancy) prior to consideration of enrollment into this trial and taking the geriatric assessment will be excluded
boolean
C0392920 (UMLS CUI [1])
C0006826 (UMLS CUI [2,1])
C0205480 (UMLS CUI [2,2])
C0017463 (UMLS CUI [3])
Uterine Cancer Preoperative | Endometrial biopsy
Item
patients who have a known pre-operative primary uterine cancer, confirmed by endometrial biopsy
boolean
C0153567 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C1510477 (UMLS CUI [2])

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