| CTRI Number |
CTRI/2024/07/069769 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Early detection of oral cancer by ERLY SIGN Kit by using saliva sample. |
|
Scientific Title of Study
|
A prospective, multi-centre, single arm, pilot clinical study to determine the accuracy of the ERLY SIGN Kit for early detection of Oral Cancer. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CB-ERSI-2022-09 Version 1.0 dated 12 April 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwini Kumar |
| Designation |
CEO |
| Affiliation |
CliniExperts Research Services Pvt Ltd |
| Address |
Unit No. 324-325, City Centre Mall, Plot No. 5, Pocket 8, Block B, Sector 12 Dwarka, Dwarka, New Delhi, Delhi, 110075
West
DELHI
110075
India |
| Phone |
9999219448 |
| Fax |
|
| Email |
ashwini.kumar@cliniexpertsresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deovrat Begde |
| Designation |
Chief Scientific Officer and Co-founder |
| Affiliation |
CURO Biosciences Private Limited |
| Address |
Plot no. 41, Darshana Society, Gorewada, Nagpur Maharashtra 440013.
Nagpur
MAHARASHTRA
440013
India |
| Phone |
9823162400 |
| Fax |
|
| Email |
deovrat@erlysign.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deovrat Begde |
| Designation |
Chief Scientific Officer and Co-founder |
| Affiliation |
CURO Biosciences Private Limited |
| Address |
Plot no. 41, Darshana Society, Gorewada, Nagpur Maharashtra 440013.
MAHARASHTRA
440013
India |
| Phone |
9823162400 |
| Fax |
|
| Email |
deovrat@erlysign.com |
|
|
Source of Monetary or Material Support
|
| CURO Biosciences Private Limited
Plot no. 41, Darshana Society, Gorewada, Nagpur Maharashtra 440013 |
|
|
Primary Sponsor
|
| Name |
CURO Biosciences Private Limited |
| Address |
Plot no. 41, Darshana Society, Gorewada, Nagpur Maharashtra 440013 |
| Type of Sponsor |
Other [Medical Device Company-Indian] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ganesh Agarwal |
HCG Abdur Razzaque Ansari Cancer Hospital |
HCG Abdur Razzaque Ansari Cancer Hospital, NH-33, IRBA Ranchi-835217, Jharkhand, India
Ranchi
JHARKHAND |
9547033671
ganesh.agarwal@hcgel.com |
| Dr Vishal Rao US |
HCG Cancer Hospital |
No. 8, P Kalinga Rao Road, HCG Towers, Tower 4, II Floor, Room No : 512, Sampangiramnagar- 560027
Bangalore
KARNATAKA |
9739774949
drvishal.rao@hcgel.com |
| Dr Ajay Mehta |
HCG NCHRI Cancer Center |
Department, Room No. 325-331, Mouja Wanjri Khasra No.50, 51 Ring Road Near Automotive Square, Kalam Bande Nawaz Nagar, Binaki, 440017
Nagpur
MAHARASHTRA |
9823190192
drajaymehta7@gmail.com |
| Dr Harish Premratan Kela |
Rashtra Sant Tukdoji Cancer Hospital and Research Centre |
Tukdoji Square, Manewada Road Nagpur, Maharashtra-440027, India
Nagpur
MAHARASHTRA |
9330166673
drharishonco@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| HCG Central Ethics CommitteeInstitutional Ethics Committee |
Approved |
| HCG NCHRI Cancer Center IEC |
Approved |
| Institutional Ethics Committee HCG CARACI |
Approved |
| Institutional Ethics Committee Rashtra Sant Tukdoji Cancer Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Volunteers for Screening |
| Patients |
(1) ICD-10 Condition: D000||Carcinoma in situ of lip, oral cavity and pharynx, (2) ICD-10 Condition: C000||Malignant neoplasm of external upper lip, (3) ICD-10 Condition: C001||Malignant neoplasm of external lower lip, (4) ICD-10 Condition: C002||Malignant neoplasm of external lip, unspecified, (5) ICD-10 Condition: C003||Malignant neoplasm of upper lip, inner aspect, (6) ICD-10 Condition: C004||Malignant neoplasm of lower lip, inner aspect, (7) ICD-10 Condition: C005||Malignant neoplasm of lip, unspecified, inner aspect, (8) ICD-10 Condition: C006||Malignant neoplasm of commissure of lip, unspecified, (9) ICD-10 Condition: C008||Malignant neoplasm of overlappingsites of lip, (10) ICD-10 Condition: C009||Malignant neoplasm of lip, unspecified, (11) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (12) ICD-10 Condition: C020||Malignant neoplasm of dorsal surface of tongue, (13) ICD-10 Condition: C021||Malignant neoplasm of border of tongue, (14) ICD-10 Condition: C022||Malignant neoplasm of ventral surface of tongue, (15) ICD-10 Condition: C028||Malignant neoplasm of overlappingsites of tongue, (16) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified, (17) ICD-10 Condition: C030||Malignant neoplasm of upper gum, (18) ICD-10 Condition: C031||Malignant neoplasm of lower gum, (19) ICD-10 Condition: C039||Malignant neoplasm of gum, unspecified, (20) ICD-10 Condition: C040||Malignant neoplasm of anterior floor of mouth, (21) ICD-10 Condition: C041||Malignant neoplasm of lateral floor of mouth, (22) ICD-10 Condition: C048||Malignant neoplasm of overlappingsites of floor of mouth, (23) ICD-10 Condition: C049||Malignant neoplasm of floor of mouth, unspecified, (24) ICD-10 Condition: C050||Malignant neoplasm of hard palate, (25) ICD-10 Condition: C051||Malignant neoplasm of soft palate, (26) ICD-10 Condition: C058||Malignant neoplasm of overlappingsites of palate, (27) ICD-10 Condition: C059||Malignant neoplasm of palate, unspecified, (28) ICD-10 Condition: C060||Malignant neoplasm of cheek mucosa, (29) ICD-10 Condition: C061||Malignant neoplasm of vestibule ofmouth, (30) ICD-10 Condition: C062||Malignant neoplasm of retromolar area, (31) ICD-10 Condition: C068||Malignant neoplasm of overlappingsites of other and unspecified parts of mouth, (32) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ERLY SIGN Kit |
ERLY SIGN kit is based on Gelatinase activity and designed for detection of proteolytic activity of a biological sample preferably a body fluid like saliva collected and maintained to preserve the enzymatic activity of the target enzyme.
An estimate of the active matrix metalloproteinases (MMPs) detected and assessed on the basis of number of gelatin layers, digested by the biological sample, of the inner segment tubes. Salivary active MMPs establish a correlation with progression of oral cancer, which this device intends to detect non-invasively to predict severity of cancer progression.​ |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
The inclusion criteria are as follows:
• Male or Female patients with age of eighteen (18) and above.
• Able to give informed consent.
• Patients meeting the inclusion criteria for one of the following study groups:
Group A:
400 Healthy Individuals Patients who give a history of:
• No smoking
• No tobacco
• No alcohol
• No systemic disease on conventional oral examination
• No visible oral lesions on conventional oral examination.
• Good oral hygiene.
Group B:
200 subjects with suspected Oral Carcinoma diagnosed with Premalignant oral lesions such as leukoplakia, erythroplakia, lichen planus, and submucous fibrosis.
Group C:
400 subjects with confirmed diagnosis of Oral Carcinoma. Patient must be diagnosed with histologically confirmed oral cavity squamous cell carcinoma (OCC) (lip, floor of mouth, anterior 2/3 tongue, buccal mucosa, upper and lower gingiva, hard palate and retromolar trigone |
|
| ExclusionCriteria |
| Details |
The exclusion criteria are as follows:
•Patients who have participated in another investigational clinical study within thirty (30) days before screening.
•Inflammation, Cut or fissures in the oral cavity which was not preview of the Oral Cancer.
•Uncontrolled hypertension, diabetes mellitus or any other co-morbidity that is considered as an exclusion by the Investigator.
• Dementia or significantly altered mental status that would limit the ability to obtain informed consent and compliance with the requirements of this protocol.
•Patients with a history of cancer other than for selected group
•Significant medical history, immune-compromised and patients with COVID19 illness at present.
•Subjects with any other clinically significant unstable medical condition, life-threatening disease, which in the opinion of the Investigator that would interfere with the study results.
• Any acute or chronic medical, psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or could interfere with interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry in the trial.
• Inability/lack of willingness to comply with visits, treatment plans, protocol assessments or laboratory tests. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the sensitivity and specificity of the ERLY SIGN Kit in identifying the active levels of MMP-2 and/or MMP-9 in saliva for early detection of Oral Cancer as compared to gold standard (Biopsy results) |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•To have a predictive scale about the progression of patients with premalignant oral lesions with highly active MMP-2 and/or MMP-9 level in the saliva to malignant oral cancer
•To calculate the correlative index of progression of patients with premalignant oral lesions with highly active levels of active MMP-2 and/or MMP-9 in the saliva to malignant oral cancer
•To establish a correlation between the medical history and habits of oral cancer patients with the active levels of MMP-2 and/or MMP-9 as determined by the proposed kit. |
90 days |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
10/07/2024 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study is a prospective, multi-center, non-randomized, pilot clinical study. Subject to inclusion, exclusion criteria and after obtaining an informed consent, subjects will be enrolled in the study. The ERLY SIGN Kit shall be used for the early detection of Oral Cancer. The study shall be done at 3+ sites with a total number of 1000 patients that meet the criteria for inclusion. The study duration is expected to be approximately 6-8 months. Defined parameters shall be recorded during the study and entered in the work sheet/CRF. Premalignant subjects, with high levels of MMP-2 and/or MMP-9 will undergo histopathological examination. Those subjects identified as positive will be considered as true positive and those with negative results will undergo a comprehensive 3-month follow-up, involving re-examination with our kit and histopathological analysis, to rigorously confirm the trajectory of disease progression. This follow up design will help us arrive at a conclusion about the utility of our kit in predicting the malignant progression of the disease. |