ID

36296

Description

Ultra Low Dose 4 Gy Orbital Radiation for Definitive Therapy of Indolent B Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02494700

Link

https://clinicaltrials.gov/show/NCT02494700

Keywords

Versions (1)
  1. 4/30/19 4/30/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 30, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Lymphoma NCT02494700

English

Eligibility Lymphoma NCT02494700

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT02494700
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients 18 years or older with stage i-iv indolent b cell lymphoma, including malt and follicular grade i/ii. patients with mantle cell lymphoma will also be included in this study, as mantle cell lymphoma is also radiosensitive, despite it not being an indolent b cell lymphoma. patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (cll/sll) are ineligible
Description

Age | B-Cell Lymphoma indolent TNM clinical staging | MALT Lymphoma Grade | Follicular Lymphoma Grade | Mantle cell lymphoma | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Ineligible

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0079731
UMLS CUI [2,2]
C0234227
UMLS CUI [2,3]
C3258246
UMLS CUI [3,1]
C0242647
UMLS CUI [3,2]
C0441800
UMLS CUI [4,1]
C0024301
UMLS CUI [4,2]
C0441800
UMLS CUI [5]
C0334634
UMLS CUI [6,1]
C1302547
UMLS CUI [6,2]
C1512714
2. patients must have measurable disease within the orbit, either clinically or radiographically after biopsy confirmation of b cell lymphoma
Description

Measurable Disease Orbital lymphoma | B-Cell Lymphoma Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0271333
UMLS CUI [2,1]
C0079731
UMLS CUI [2,2]
C0005558
3. bilateral ocular adnexal involvement is permitted, if biopsy confirms unilateral disease and there is high clinical suspicion for bilateral disease, biopsy of the contralateral ocular adnexa can be waived.
Description

Involvement with Ocular adnexa Bilateral | Unilateral disease Biopsy | Suspicion High Bilateral Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1314939
UMLS CUI [1,2]
C0229243
UMLS CUI [1,3]
C0238767
UMLS CUI [2,1]
C4035394
UMLS CUI [2,2]
C0005558
UMLS CUI [3,1]
C0242114
UMLS CUI [3,2]
C0205250
UMLS CUI [3,3]
C1511113
4. female patients of childbearing potential must have a negative serum pregnancy test (beta-hcg) within 2 weeks of protocol entry.
Description

Childbearing Potential Serum pregnancy test (B-HCG) Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430060
UMLS CUI [1,3]
C1513916
5. planned systemic therapy after orbital radiation therapy is permitted however the timing of systemic therapy will be recorded and patients will be stratified according to receipt of adjuvant systemic therapy.
Description

Systemic therapy Planned | Status post Irradiation of orbit

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C2148573
6. male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study
Description

Gender Barrier Contraception | Gender Sexual Abstinence Heterosexual

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0004764
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0036899
UMLS CUI [2,3]
C0019421
7. female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post-menopausal (free from menses > two years or surgically sterilized).
Description

Gender Barrier Contraception Double | Gender Sexual Abstinence Heterosexual | Postmenopausal state | Female Sterilization

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0004764
UMLS CUI [1,3]
C0205173
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0036899
UMLS CUI [2,3]
C0019421
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0015787
8. patients must have the ability to give informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients treated with chemotherapy within 4 weeks of protocol enrollment (including rituxan).
Description

Chemotherapy | Rituxan

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0732355
2. patients with aggressive b cell lymphoma histology, including diffuse large b cell lymphoma (dlbcl) and grade 3 follicular lymphoma.
Description

B-Cell Lymphomas | Diffuse Large B-Cell Lymphoma | Follicular Lymphoma Grade

Data type

boolean

Alias
UMLS CUI [1]
C0079731
UMLS CUI [2]
C0079744
UMLS CUI [3,1]
C0024301
UMLS CUI [3,2]
C0441800
3. patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (cll/sll)
Description

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C1302547
4. patients with a history of prior radiation to the orbit if re-treatment would exceed known orbital tolerance
Description

Irradiation of orbit Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C2148573
UMLS CUI [1,2]
C0205156
5. patients with pre-existing retinopathy
Description

Retinal Disease Pre-existing

Data type

boolean

Alias
UMLS CUI [1,1]
C0035309
UMLS CUI [1,2]
C2347662
6. patients who are pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
7. patients with active lupus or scleroderma are ineligible
Description

Lupus Erythematosus | Scleroderma

Data type

boolean

Alias
UMLS CUI [1]
C0409974
UMLS CUI [2]
C0011644
Back to the top of the page

Similar models

Eligibility Lymphoma NCT02494700

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT02494700
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | B-Cell Lymphoma indolent TNM clinical staging | MALT Lymphoma Grade | Follicular Lymphoma Grade | Mantle cell lymphoma | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Ineligible
Item
1. patients 18 years or older with stage i-iv indolent b cell lymphoma, including malt and follicular grade i/ii. patients with mantle cell lymphoma will also be included in this study, as mantle cell lymphoma is also radiosensitive, despite it not being an indolent b cell lymphoma. patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (cll/sll) are ineligible
boolean
C0001779 (UMLS CUI [1])
C0079731 (UMLS CUI [2,1])
C0234227 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C0242647 (UMLS CUI [3,1])
C0441800 (UMLS CUI [3,2])
C0024301 (UMLS CUI [4,1])
C0441800 (UMLS CUI [4,2])
C0334634 (UMLS CUI [5])
C1302547 (UMLS CUI [6,1])
C1512714 (UMLS CUI [6,2])
Measurable Disease Orbital lymphoma | B-Cell Lymphoma Biopsy
Item
2. patients must have measurable disease within the orbit, either clinically or radiographically after biopsy confirmation of b cell lymphoma
boolean
C1513041 (UMLS CUI [1,1])
C0271333 (UMLS CUI [1,2])
C0079731 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
Involvement with Ocular adnexa Bilateral | Unilateral disease Biopsy | Suspicion High Bilateral Disease
Item
3. bilateral ocular adnexal involvement is permitted, if biopsy confirms unilateral disease and there is high clinical suspicion for bilateral disease, biopsy of the contralateral ocular adnexa can be waived.
boolean
C1314939 (UMLS CUI [1,1])
C0229243 (UMLS CUI [1,2])
C0238767 (UMLS CUI [1,3])
C4035394 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0242114 (UMLS CUI [3,1])
C0205250 (UMLS CUI [3,2])
C1511113 (UMLS CUI [3,3])
Childbearing Potential Serum pregnancy test (B-HCG) Negative
Item
4. female patients of childbearing potential must have a negative serum pregnancy test (beta-hcg) within 2 weeks of protocol entry.
boolean
C3831118 (UMLS CUI [1,1])
C0430060 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Systemic therapy Planned | Status post Irradiation of orbit
Item
5. planned systemic therapy after orbital radiation therapy is permitted however the timing of systemic therapy will be recorded and patients will be stratified according to receipt of adjuvant systemic therapy.
boolean
C1515119 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C2148573 (UMLS CUI [2,2])
Gender Barrier Contraception | Gender Sexual Abstinence Heterosexual
Item
6. male patients must agree to use a barrier method of contraception or agree to abstain from heterosexual activity for the duration of the study
boolean
C0079399 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C0019421 (UMLS CUI [2,3])
Gender Barrier Contraception Double | Gender Sexual Abstinence Heterosexual | Postmenopausal state | Female Sterilization
Item
7. female patients must be willing to use two adequate barrier methods of contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study or be post-menopausal (free from menses > two years or surgically sterilized).
boolean
C0079399 (UMLS CUI [1,1])
C0004764 (UMLS CUI [1,2])
C0205173 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0036899 (UMLS CUI [2,2])
C0019421 (UMLS CUI [2,3])
C0232970 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
Informed Consent
Item
8. patients must have the ability to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Rituxan
Item
1. patients treated with chemotherapy within 4 weeks of protocol enrollment (including rituxan).
boolean
C0392920 (UMLS CUI [1])
C0732355 (UMLS CUI [2])
B-Cell Lymphomas | Diffuse Large B-Cell Lymphoma | Follicular Lymphoma Grade
Item
2. patients with aggressive b cell lymphoma histology, including diffuse large b cell lymphoma (dlbcl) and grade 3 follicular lymphoma.
boolean
C0079731 (UMLS CUI [1])
C0079744 (UMLS CUI [2])
C0024301 (UMLS CUI [3,1])
C0441800 (UMLS CUI [3,2])
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Item
3. patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (cll/sll)
boolean
C1302547 (UMLS CUI [1])
Irradiation of orbit Previous
Item
4. patients with a history of prior radiation to the orbit if re-treatment would exceed known orbital tolerance
boolean
C2148573 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Retinal Disease Pre-existing
Item
5. patients with pre-existing retinopathy
boolean
C0035309 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Pregnancy
Item
6. patients who are pregnant
boolean
C0032961 (UMLS CUI [1])
Lupus Erythematosus | Scleroderma
Item
7. patients with active lupus or scleroderma are ineligible
boolean
C0409974 (UMLS CUI [1])
C0011644 (UMLS CUI [2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial