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Compares treatment options for Mouth Neoplasms
Official title Sentinel Node Biopsy Versus Limited Elective Neck Dissection in Early Cancers of Oral Cavity NoDe Negative
ClinicalTrials.gov ID: NCT05774483
What this study is testing
- What it's testing
- The goal of this clinical trial is to compare the survival outcomes, morbidity and cost-effectiveness of sentinel node biopsy versus limited elective neck dissection in node-negative early oral cancers. The main questions it aims to answer are: Survival outcomes Morbidity outcomes Cost-effectiveness Participants will either undergo sentinel node biopsy followed by completion neck dissection if sentinel node is reported to be metastatic (SNB) or limited elective neck dissection where level IIb will be cleared only if level IIa is metastatic (limited END).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age \>18 years of age
- Biopsy-proven invasive squamous cell carcinoma involving the site tongue and buccal mucosa
- T1 and T2 lesions as per AJCC TNM 8 edition
- Clinicoradiologically node negative
- Amenable to per oral excision
You likely can't join if
- Previous surgery in the head and neck region,
- Upper alveolar or palatal lesions
- Large heterogeneous leukoplakia or other premalignant lesions
- Previous malignancy in the head and neck region
- Patients requiring the free flap reconstruction
See the full eligibility criteria
- Age \>18 years of age
- Biopsy-proven invasive squamous cell carcinoma involving the site tongue and buccal mucosa
- T1 and T2 lesions as per AJCC TNM 8 edition
- Clinicoradiologically node negative
- Amenable to per oral excision
- Treatment naïve
- No other site of malignancy
- Previous surgery in the head and neck region,
- Upper alveolar or palatal lesions
- Large heterogeneous leukoplakia or other premalignant lesions
- Previous malignancy in the head and neck region
- Patients requiring the free flap reconstruction
The study team makes the final eligibility decision.
Where it's taking place
- Mumbai, Maharashtra, India
- Navi Mumbai, Maharashtra, India
- Varanasi, Uttar Pradesh, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mumbai, Maharashtra, India; Navi Mumbai, Maharashtra, India; Varanasi, Uttar Pradesh, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.