ID

36944

Description

Search for Predictors of Therapeutic Response in Ovarian Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01391351 In order to search for predictors of response to chemotherapy in patients with ovarian carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage, we will define the comparative profiles of miRNA expression of serum polymorphisms and determine differential in 2 patient populations (with or without recurrence 6 months after completion of chemotherapy) with (i) the miRNA profile of serum before treatment and (ii) identification of polymorphisms or SNP (Single Nucleotide Polymorphism) in particular genes involved in the metabolism of chemotherapy agents In the case of miRNA, expression profiles will also be studied during the first course in response to chemotherapy. Indeed, the miRNA profile of serum may be different at baseline among the 2 types of populations (or non-recurrence at 6 months).

Link

https://clinicaltrials.gov/show/NCT01391351

Keywords

Versions (1)
  1. 6/23/19 6/23/19 -
Copyright Holder

Centre Francois Baclesse

Uploaded on

June 23, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Predictors of Therapeutic Response in Ovarian Carcinoma NCT01391351

English

Eligibility Criteria

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Does the participant have cancer of the ovary, peritoneum or of the fallopian tube?
Description

Ovarian, Peritoneal or Fallopian Tube Cancer

Data type

boolean

Alias
UMLS CUI [1]
C1140680
UMLS CUI [2]
C0153467
UMLS CUI [3]
C0153579
Does the participant have stage III or IV?
Description

Stage III/IV

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205578
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0205585
Does the participant have a cancer of serous histology?
Description

Serous histology

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0440743
UMLS CUI [1,3]
C0019638
Is the participant naive of any chemotherapy?
Description

Chemotherapy naive

Data type

boolean

Alias
UMLS CUI [1,1]
C3665472
UMLS CUI [1,2]
C0919936
Will the participant receive treatment with chemotherapy for first line by taxol-Carboplatin?
Description

Avastin is authorized in concomitant.

Data type

boolean

Alias
UMLS CUI [1,1]
C0678133
UMLS CUI [1,2]
C0079083
UMLS CUI [1,3]
C0205195
UMLS CUI [1,4]
C1708063
Will the participant receive and an initial surgery?
Description

Initial surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0205265
UMLS CUI [1,2]
C0543467
Has the participant signed informed consent?
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Is the participant over the age of 18 years?
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Is the participant being treated for another cancer chemotherapy and/or hormone therapy?
Description

Other hormone or chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C3665472
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0279025
Is the participant receiving other chemotherapy taxol-carboplatin associated or not to avastin?
Description

Taxol Carboplatin associated chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C3665472
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0678133
UMLS CUI [2,1]
C3665472
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0079083
UMLS CUI [3,1]
C3665472
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C1135130
Is the participant under guardianship?
Description

Guardianship

Data type

boolean

Alias
UMLS CUI [1]
C0870627
previous history of pelvic radiotherapy
Description

Prior pelvic radiotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0030797
UMLS CUI [1,3]
C1522449
Does the partipant have a history of malignancy blood?
Description

History of hematologic malignancy

Data type

boolean

Alias
UMLS CUI [1]
C3696964
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Similar models

Eligibility Criteria

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Ovarian, Peritoneal or Fallopian Tube Cancer
Item
Does the participant have cancer of the ovary, peritoneum or of the fallopian tube?
boolean
C1140680 (UMLS CUI [1])
C0153467 (UMLS CUI [2])
C0153579 (UMLS CUI [3])
Stage III/IV
Item
Does the participant have stage III or IV?
boolean
C0006826 (UMLS CUI [1,1])
C0205578 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C0205585 (UMLS CUI [2,2])
Serous histology
Item
Does the participant have a cancer of serous histology?
boolean
C0006826 (UMLS CUI [1,1])
C0440743 (UMLS CUI [1,2])
C0019638 (UMLS CUI [1,3])
Chemotherapy naive
Item
Is the participant naive of any chemotherapy?
boolean
C3665472 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
Taxol Carboplatin first-line therapy
Item
Will the participant receive treatment with chemotherapy for first line by taxol-Carboplatin?
boolean
C0678133 (UMLS CUI [1,1])
C0079083 (UMLS CUI [1,2])
C0205195 (UMLS CUI [1,3])
C1708063 (UMLS CUI [1,4])
Initial surgery
Item
Will the participant receive and an initial surgery?
boolean
C0205265 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Informed Consent
Item
Has the participant signed informed consent?
boolean
C0021430 (UMLS CUI [1])
Age
Item
Is the participant over the age of 18 years?
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Other hormone or chemotherapy
Item
Is the participant being treated for another cancer chemotherapy and/or hormone therapy?
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C3665472 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0279025 (UMLS CUI [2,3])
Taxol Carboplatin associated chemotherapy
Item
Is the participant receiving other chemotherapy taxol-carboplatin associated or not to avastin?
boolean
C3665472 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0678133 (UMLS CUI [1,3])
C3665472 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0079083 (UMLS CUI [2,3])
C3665472 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C1135130 (UMLS CUI [3,3])
Guardianship
Item
Is the participant under guardianship?
boolean
C0870627 (UMLS CUI [1])
Prior pelvic radiotherapy
Item
previous history of pelvic radiotherapy
boolean
C0262926 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,3])
History of hematologic malignancy
Item
Does the partipant have a history of malignancy blood?
boolean
C3696964 (UMLS CUI [1])
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