| CTRI Number |
CTRI/2025/02/081124 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study outcome parameters in a specific cancer AdCC(Adenoid Cystic carcinoma) of Head and Neck region. |
|
Scientific Title of Study
|
Predictors of clinical outcomes in Adenoid Cystic Carcinoma of Head and Neck : An Ambispective Analysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Dinesh Kumar Sharma |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, New Delhi. |
| Address |
Department of ENT, AIIMS New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
7018028547 |
| Fax |
|
| Email |
denish.doc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kapil Sikka |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi. |
| Address |
Department of ENT, AIIMS New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
9810423088 |
| Fax |
|
| Email |
kapil_sikka@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Dinesh Kumar Sharma |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, New Delhi. |
| Address |
Department of ENT, AIIMS, New Delhi.
New Delhi
DELHI
110029
India |
| Phone |
7018028547 |
| Fax |
|
| Email |
denish.doc@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar East, New Delhi -110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of ENT, All India Institute Of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar East, New Delhi -110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Kapil Sikka |
Department Of ENT, All India Institute Of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar East, New Delhi -110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dinesh Kumar Sharma |
AIIMS New Delhi |
Department of ENT, All India Institute Of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar East, New Delhi -110029
New Delhi
DELHI |
07018028547
denish.doc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for post graduate research , AIIMS, Ansari Nagar, New Delhi. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Histologically proven Adenoid Cystic Carcinoma.
Site - Head and neck region.
Subsites - Nose, PNS, Orbit, Ear, Oral cavity, Pharynx, Larynx, Salivary Glands.
Stage- I to IV as per AJCC 8th edition.
Treated by any of the modalities at AIIMS or NCI JAJJHAR from JAN. 2014 till DEC. 2025. |
|
| ExclusionCriteria |
| Details |
Non Adenoid Cystic Histology.
Patient not giving consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Survival Outcomes - OS(Overall Survival), LRRFS(Loco-Regional Recurrence Free Survival), DFS(Disease Free Survival). |
At 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| QOL(Quality Of Life) |
3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM AND OBJECTIVES
Aim:
To assess the predictors of clinical outcomes
in patients of Adenoid Cystic carcinoma of the head and neck.
Objectives
Primary Objectives
a)
To
study the demographic, clinical, radiological, and pathological distribution in patients of Head
and Neck Adenoid Cystic Carcinoma treated by surgical or non- surgical
modalities. (age, sex, socioeconomic status,
comorbidities, grade, stage, nodal status,
distant metastasis, previous
treatment, histological report,
margin status, adjuvant
therapy etc.).
b)
To
study the impact of these clinicopathological factors
on survival outcomes
(Overall Survival - OS, Loco Regional Recurrence Free Survival – LRRFS,
and Disease- Free Survival – DFS).
Secondary Objectives
a) To determine the Quality of Life (QoL) in AdCC
patients.
b)
To
ascertain differences in outcomes of major versus minor salivary
gland AdCC and localized disease
versus distant metastatic disease.
c)
To
study association of NOTCH1 mutations
with AdCC and its impact
on survival outcomes (Subject to funding).
Material and Methods
Study Design
– Ambispective Observational Study
Study Duration
– One and a half years
Study Setting
1.
Department of Otorhinolaryngology
and Head-Neck Surgery, All India Institute of Medical Sciences,
New Delhi (AIIMS)
2.
Department of Head and Neck Oncology,
National Cancer Institute, Jhajjar, Haryana (NCI)
3.
Head and Neck Lab, Department of
Pathology, AIIMS, New Delhi. |