ID

43946

Description

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

Keywords

Versions (2)
  1. 5/19/16 5/19/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Fallopian Tube Carcinoma NCT02315469

English

Eligibility Fallopian Tube Carcinoma NCT02315469

1 forms  
Inclusion Criteria
Description

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
Description

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

Data type

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
Description

Informed Consent

Data type

boolean

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

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

Data type

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
Description

Patients | Caregiver | Consent | Response Questionnaires

Data type

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
Description

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

Data type

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
Description

Pathology Postoperative

Data type

boolean

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

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
Description

Life circumstances Compliance behavior Limited

Data type

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
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0282624
UMLS CUI [2]
C3850079
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
Description

Chemotherapy Regimen | Malignant Neoplasms Gynecologic | Geriatric Assessment

Data type

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
Description

Uterine Cancer Preoperative | Endometrial biopsy

Data type

boolean

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

Eligibility Fallopian Tube Carcinoma NCT02315469

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
C3850079 (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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