ID

41005

Description

Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00911326

Link

https://clinicaltrials.gov/show/NCT00911326

Keywords

Versions (1)
  1. 6/10/20 6/10/20 -
Copyright Holder

See clinicaltrials.gov

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June 10, 2020

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License

Creative Commons BY 4.0
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Eligibility Head and Neck Squamous Cell Carcinoma (HNSCC) NCT00911326

English

Eligibility Head and Neck Squamous Cell Carcinoma (HNSCC) NCT00911326

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects meeting all of the following inclusion criteria by the end of the screening phase should be considered for admission to the study:
Description

Inclusion criteria All Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0444868
UMLS CUI [1,3]
C1550543
1. the patient has provided written informed consent with health insurance portability and accountability act (hipaa) authorization before participating in the study.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. the patient has a diagnosis of primary squamous cell carcinoma of the head and neck either cutaneous or intra-oral that is anatomically located in: mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingiva (retromolar trigone), floor of the mouth, hard palette or oral (mobile) tongue, stage t1-t4a, n0, m0.
Description

Cutaneous Squamous Cell Carcinoma of the Head and Neck TNM clinical staging | Squamous cell carcinoma of the head and neck Oral TNM clinical staging | Anatomic Site | Lip mucosal | Buccal mucosa | Lower alveolar ridge | Upper alveolar ridge | Gingiva Retromolar | Retromolar trigone | Sublingual Region | Hard Palate | Tongue

Data type

boolean

Alias
UMLS CUI [1,1]
C4524517
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C1168401
UMLS CUI [2,2]
C0442027
UMLS CUI [2,3]
C3258246
UMLS CUI [3]
C1515974
UMLS CUI [4]
C2184041
UMLS CUI [5]
C1578559
UMLS CUI [6]
C0447415
UMLS CUI [7]
C0447412
UMLS CUI [8,1]
C0017562
UMLS CUI [8,2]
C4247023
UMLS CUI [9]
C0226920
UMLS CUI [10]
C0026638
UMLS CUI [11]
C0226901
UMLS CUI [12]
C0040408
3. clinical nodal staging (n0) has been confirmed by negative results from contrast ct scan or gadolinium-enhanced mri or lateral and central neck ultrasound. pet scan cannot be used for this evaluation.
Description

Lymph nodes TNM clinical staging | Result Negative CT scan contrast | Result Negative Nuclear magnetic resonance imaging gadolinium-enhanced | Result Negative Ultrasonography Lateral portion of neck | Result Negative Ultrasound of neck

Data type

boolean

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C1274040
UMLS CUI [2,2]
C1513916
UMLS CUI [2,3]
C0742919
UMLS CUI [3,1]
C1274040
UMLS CUI [3,2]
C1513916
UMLS CUI [3,3]
C0855566
UMLS CUI [4,1]
C1274040
UMLS CUI [4,2]
C1513916
UMLS CUI [4,3]
C0041618
UMLS CUI [4,4]
C1284880
UMLS CUI [5,1]
C1274040
UMLS CUI [5,2]
C1513916
UMLS CUI [5,3]
C0845880
4. imaging of the regional nodal basin has been performed within 30 days of the planned lymphadenectomy.
Description

Lymph nodes regional Imaging | Lymph node excision Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C0205147
UMLS CUI [1,3]
C0011923
UMLS CUI [2,1]
C0024203
UMLS CUI [2,2]
C1301732
5. the patient is a candidate for surgical intervention, with intraoperative lymphatic mapping and end included in the surgical plan.
Description

Patient Eligible Surgical intervention

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C0549433
6. patients with prior malignancy are allowed provided the patient meets the following criteria:
Description

Malignant Neoplasm Previous | Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1550543
underwent potentially curative therapy for all prior malignancies and is deemed low risk for recurrence; and no malignancy for the past 5 years (except effectively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix effectively treated with surgery alone, lobular carcinoma in situ of the ipsilateral or contralateral breast treated with surgery alone, or carcinoma of the mouth that is in situ or minimally invasive) and no evidence of recurrence.
Description

Curative treatment Malignant Neoplasms | Low Risk Recurrence | Malignant Neoplasm Absent Duration | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Surgery Carcinoma in situ of uterine cervix | Exception Surgery Lobular carcinoma in situ of breast Ipsilateral | Exception Surgery Lobular carcinoma in situ of breast Contralateral | Exception Carcinoma in situ of mouth | Exception Oral Cavity Carcinoma Minimally Invasive | Recurrence Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1273390
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C3538919
UMLS CUI [2,2]
C0034897
UMLS CUI [3,1]
C0006826
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0449238
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007117
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0553723
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0543467
UMLS CUI [6,3]
C0851140
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0543467
UMLS CUI [7,3]
C0279563
UMLS CUI [7,4]
C0441989
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0543467
UMLS CUI [8,3]
C0279563
UMLS CUI [8,4]
C0441988
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0347073
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0151546
UMLS CUI [10,3]
C1881856
UMLS CUI [11,1]
C0034897
UMLS CUI [11,2]
C0332197
| C1705847 | C1705847
NA
7. the patient is at least 18 years of age at the time of consent.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
8. the patient has an eastern cooperative oncology group (ecog) status of grade 0 - 2.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
9. if the patient is a female, the patient has a confirmed negative pregnancy test within 72 hours priors to administration of lymphoseek, or has documentation of surgical sterilization, or has documented evidence of postmenopausal status for at least 1 year.
Description

Gender Pregnancy test negative | Female Sterilization | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0427780
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0232970
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients meeting any of the following exclusion criteria at the end of the screening phase will not be enrolled in the study:
Description

Exclusion Criteria Any Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1552551
UMLS CUI [1,3]
C1550543
1. the patient has a diagnosis of squamous cell carcinoma of the head and neck in the following anatomical areas: non-mobile base of the tongue, oral pharynx, nasal pharynx, hypo-pharynx and larynx.
Description

Squamous cell carcinoma of the head and neck | Anatomic Site | Root of tongue | Oropharyngeal | Nasal pharynx | Hypopharynx | Larynx

Data type

boolean

Alias
UMLS CUI [1]
C1168401
UMLS CUI [2]
C1515974
UMLS CUI [3]
C0226958
UMLS CUI [4]
C0521367
UMLS CUI [5]
C2371882
UMLS CUI [6]
C0020629
UMLS CUI [7]
C0023078
2. the patient is pregnant or lactating.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. the patient has clinical or radiological evidence of metastatic cancer to the regional lymph nodes.
Description

Regional lymph node metastasis present

Data type

boolean

Alias
UMLS CUI [1]
C1275854
4. patients with a history of neck dissection, or gross injury to the neck that would preclude reasonable surgical dissection for this study, or radiotherapy to the neck.
Description

Neck Dissection | Neck Injury Gross | Radiotherapy to neck

Data type

boolean

Alias
UMLS CUI [1]
C0398395
UMLS CUI [2,1]
C0027531
UMLS CUI [2,2]
C0439806
UMLS CUI [3]
C1997944
5. patients who have had other nuclear imaging studies conducted within 15 days or consenting.
Description

Other nuclear medicine imaging study

Data type

boolean

Alias
UMLS CUI [1]
C0841699
6. the patient is actively receiving systemic cytotoxic chemotherapy.
Description

Cytotoxic Chemotherapy Systemic

Data type

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0205373
7. patient is currently participating in another investigational drug study or participated within 30 days prior to consenting.
Description

Study Subject Participation Status | Clinical Trial Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0013230
8. patient is on immunosuppressive or anti-monocyte or immunomodulatory therapy.
Description

Therapeutic immunosuppression | Other Coding | Immunomodulatory therapy

Data type

boolean

Alias
UMLS CUI [1]
C0021079
UMLS CUI [2]
C3846158
UMLS CUI [3]
C1963758
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Similar models

Eligibility Head and Neck Squamous Cell Carcinoma (HNSCC) NCT00911326

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Inclusion criteria All Fulfill
Item
subjects meeting all of the following inclusion criteria by the end of the screening phase should be considered for admission to the study:
boolean
C1512693 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Informed Consent
Item
1. the patient has provided written informed consent with health insurance portability and accountability act (hipaa) authorization before participating in the study.
boolean
C0021430 (UMLS CUI [1])
Cutaneous Squamous Cell Carcinoma of the Head and Neck TNM clinical staging | Squamous cell carcinoma of the head and neck Oral TNM clinical staging | Anatomic Site | Lip mucosal | Buccal mucosa | Lower alveolar ridge | Upper alveolar ridge | Gingiva Retromolar | Retromolar trigone | Sublingual Region | Hard Palate | Tongue
Item
2. the patient has a diagnosis of primary squamous cell carcinoma of the head and neck either cutaneous or intra-oral that is anatomically located in: mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingiva (retromolar trigone), floor of the mouth, hard palette or oral (mobile) tongue, stage t1-t4a, n0, m0.
boolean
C4524517 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1168401 (UMLS CUI [2,1])
C0442027 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C1515974 (UMLS CUI [3])
C2184041 (UMLS CUI [4])
C1578559 (UMLS CUI [5])
C0447415 (UMLS CUI [6])
C0447412 (UMLS CUI [7])
C0017562 (UMLS CUI [8,1])
C4247023 (UMLS CUI [8,2])
C0226920 (UMLS CUI [9])
C0026638 (UMLS CUI [10])
C0226901 (UMLS CUI [11])
C0040408 (UMLS CUI [12])
Lymph nodes TNM clinical staging | Result Negative CT scan contrast | Result Negative Nuclear magnetic resonance imaging gadolinium-enhanced | Result Negative Ultrasonography Lateral portion of neck | Result Negative Ultrasound of neck
Item
3. clinical nodal staging (n0) has been confirmed by negative results from contrast ct scan or gadolinium-enhanced mri or lateral and central neck ultrasound. pet scan cannot be used for this evaluation.
boolean
C0024204 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1274040 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0742919 (UMLS CUI [2,3])
C1274040 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
C0855566 (UMLS CUI [3,3])
C1274040 (UMLS CUI [4,1])
C1513916 (UMLS CUI [4,2])
C0041618 (UMLS CUI [4,3])
C1284880 (UMLS CUI [4,4])
C1274040 (UMLS CUI [5,1])
C1513916 (UMLS CUI [5,2])
C0845880 (UMLS CUI [5,3])
Lymph nodes regional Imaging | Lymph node excision Planned
Item
4. imaging of the regional nodal basin has been performed within 30 days of the planned lymphadenectomy.
boolean
C0024204 (UMLS CUI [1,1])
C0205147 (UMLS CUI [1,2])
C0011923 (UMLS CUI [1,3])
C0024203 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Patient Eligible Surgical intervention
Item
5. the patient is a candidate for surgical intervention, with intraoperative lymphatic mapping and end included in the surgical plan.
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0549433 (UMLS CUI [1,3])
Malignant Neoplasm Previous | Criteria Fulfill
Item
6. patients with prior malignancy are allowed provided the patient meets the following criteria:
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0243161 (UMLS CUI [2,1])
C1550543 (UMLS CUI [2,2])
Curative treatment Malignant Neoplasms | Low Risk Recurrence | Malignant Neoplasm Absent Duration | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Surgery Carcinoma in situ of uterine cervix | Exception Surgery Lobular carcinoma in situ of breast Ipsilateral | Exception Surgery Lobular carcinoma in situ of breast Contralateral | Exception Carcinoma in situ of mouth | Exception Oral Cavity Carcinoma Minimally Invasive | Recurrence Absent
Item
underwent potentially curative therapy for all prior malignancies and is deemed low risk for recurrence; and no malignancy for the past 5 years (except effectively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix effectively treated with surgery alone, lobular carcinoma in situ of the ipsilateral or contralateral breast treated with surgery alone, or carcinoma of the mouth that is in situ or minimally invasive) and no evidence of recurrence.
boolean
C1273390 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C3538919 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0449238 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007117 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0553723 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0543467 (UMLS CUI [6,2])
C0851140 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0543467 (UMLS CUI [7,2])
C0279563 (UMLS CUI [7,3])
C0441989 (UMLS CUI [7,4])
C1705847 (UMLS CUI [8,1])
C0543467 (UMLS CUI [8,2])
C0279563 (UMLS CUI [8,3])
C0441988 (UMLS CUI [8,4])
C1705847 (UMLS CUI [9,1])
C0347073 (UMLS CUI [9,2])
C1705847 (UMLS CUI [10,1])
C0151546 (UMLS CUI [10,2])
C1881856 (UMLS CUI [10,3])
C0034897 (UMLS CUI [11,1])
C0332197 (UMLS CUI [11,2])
NA (| C1705847 | C1705847)
Age
Item
7. the patient is at least 18 years of age at the time of consent.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
8. the patient has an eastern cooperative oncology group (ecog) status of grade 0 - 2.
boolean
C1520224 (UMLS CUI [1])
Gender Pregnancy test negative | Female Sterilization | Postmenopausal state
Item
9. if the patient is a female, the patient has a confirmed negative pregnancy test within 72 hours priors to administration of lymphoseek, or has documentation of surgical sterilization, or has documented evidence of postmenopausal status for at least 1 year.
boolean
C0079399 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Any Fulfill
Item
patients meeting any of the following exclusion criteria at the end of the screening phase will not be enrolled in the study:
boolean
C0680251 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Squamous cell carcinoma of the head and neck | Anatomic Site | Root of tongue | Oropharyngeal | Nasal pharynx | Hypopharynx | Larynx
Item
1. the patient has a diagnosis of squamous cell carcinoma of the head and neck in the following anatomical areas: non-mobile base of the tongue, oral pharynx, nasal pharynx, hypo-pharynx and larynx.
boolean
C1168401 (UMLS CUI [1])
C1515974 (UMLS CUI [2])
C0226958 (UMLS CUI [3])
C0521367 (UMLS CUI [4])
C2371882 (UMLS CUI [5])
C0020629 (UMLS CUI [6])
C0023078 (UMLS CUI [7])
Pregnancy | Breast Feeding
Item
2. the patient is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Regional lymph node metastasis present
Item
3. the patient has clinical or radiological evidence of metastatic cancer to the regional lymph nodes.
boolean
C1275854 (UMLS CUI [1])
Neck Dissection | Neck Injury Gross | Radiotherapy to neck
Item
4. patients with a history of neck dissection, or gross injury to the neck that would preclude reasonable surgical dissection for this study, or radiotherapy to the neck.
boolean
C0398395 (UMLS CUI [1])
C0027531 (UMLS CUI [2,1])
C0439806 (UMLS CUI [2,2])
C1997944 (UMLS CUI [3])
Other nuclear medicine imaging study
Item
5. patients who have had other nuclear imaging studies conducted within 15 days or consenting.
boolean
C0841699 (UMLS CUI [1])
Cytotoxic Chemotherapy Systemic
Item
6. the patient is actively receiving systemic cytotoxic chemotherapy.
boolean
C0677881 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Study Subject Participation Status | Clinical Trial Investigational New Drugs
Item
7. patient is currently participating in another investigational drug study or participated within 30 days prior to consenting.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Therapeutic immunosuppression | Other Coding | Immunomodulatory therapy
Item
8. patient is on immunosuppressive or anti-monocyte or immunomodulatory therapy.
boolean
C0021079 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
C1963758 (UMLS CUI [3])
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