| CTRI Number |
CTRI/2022/11/047316 [Registered on: 15/11/2022] Trial Registered Prospectively |
| Last Modified On: |
07/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
HER-2/neu biomarker expression in pre cancerous and cancerous lesions of uterus cervix |
|
Scientific Title of Study
|
HER-2/neu expression in Premalignant and Malignant epithelial lesions of Uterine Cervix-A cross sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nitesh Mohan |
| Designation |
Professor and Head of Department |
| Affiliation |
Rohilkhand medical college and hospital , Bareilly |
| Address |
Room no. 1165,
Department of Pathology,
Rohilkhand Medical College and Hospital, Bareilly.
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9997872559 |
| Fax |
|
| Email |
drnitesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Simona Ranjan |
| Designation |
Junior Resident, pathology |
| Affiliation |
Rohilkhand Medical College and Hospital, Bareilly. |
| Address |
Room No. 33, PG girls hostel-2,
Rohilkhand Medical College and Hospital, Bareilly.
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9667301161 |
| Fax |
|
| Email |
simonaranjan31@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitesh Mohan |
| Designation |
Professor and Head of Department |
| Affiliation |
Rohilkhand medical college and hospital , Bareilly |
| Address |
Room no. 1165,
Department of Pathology,
Rohilkhand Medical College and Hospital, Bareilly.
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9997872559 |
| Fax |
|
| Email |
drnitesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand Medical College and Hospital, Bareilly |
|
|
Primary Sponsor
|
| Name |
Rohilkhand Medical College and Hospital |
| Address |
Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Opp. Suresh Sharma Nagar, Bareilly. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nitesh Mohan |
Rohilkhand Medical College and Hospital |
Room no. 1165
Rohilkhand Medical College and Hospital, Pilibhit Bypass Road, Bareilly
Bareilly
UTTAR PRADESH |
9997872559
drnitesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, RMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
All histologically diagnosed cases of premalignant and malignant epithelial lesions of cervix received in Department of Pathology in Rohilkhand Medical College and Hospital during study period. |
|
| ExclusionCriteria |
| Details |
All histologically proven cases of inflammatory, benign lesions and stromal tumors of uterine cervix; inadequate biopsy specimen; patients already on treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Immunohistochemical expression of HER-2/neu in premalignant and malignant epithelial lesions of uterine cervix. |
Baseline investigation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
20/11/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cervical cancer is a serious global public health issue that affects women. Worldwide cervical cancer was responsible for more than 340000 fatalities in 2020. It ranks second among those under 50 years old and the fourth most common cause of cancer related death in women overall.[1] 16 percent of all cervical cancer cases and 15.2 percent of all cervical cancer death worldwide occur in India, respectively. In India 122,844 women diagnosed with cervical cancer each year and 67,477 of these women dies as a result of the illness.Cervical cancer incidence peaks between the ages of 55 and 59 years. The high prevalence of cervical cancer in poor countries like India is mostly attributed to a lack of awareness campaign and official screening programmes as a result of which the majority of women present with cervical cancer in advanced stages. Cervical cancer is responsible for 90 percent of deaths in low and middleincome nations.[2] The primary etiological agent of cervical carcinogenesis is the human papilloma virus. It results in DNA damage, aberrant centrosomes, epigenetic alterations and DNA methylation.[2] Squamous morphology makes up about 70 percent of cervical carcinomas. Invasive carcinoma develops from premalignant cervical lesions over time. Therefore most lesions can be detected early on by screening programmes, before they progress to malignancy. Numerous tissue indicator has been investigated in cervical cancer, opening the door to targeted therapy and treatment for later stages of the condition. Oncogenes are the focus of extensive research into how different malignancies originate.The development of effective anti-cancer medicines depends critically on the discovery of novel markers with prognostic or predictive value. One of the growth receptor families that has been explored the most is the HER family.The c-erbB-2 proto-oncogene, also known by the name HER-2/neu,(HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR-2) is a gene on chromosome 17q21 that encode for growth factor receptor like molecule with tyrosine kinase activity. [3-4] Its structure is similar to that of the epidermal growth factor receptor and has 1255 aminoacids. Its expression is thought to be linked to poor prognosis, aggressive biological behaviour and propensity for metastasis in a number of human malignancies.[5] It has been noted that the majority of patients with IB to IIIB stage cancers do not respond to standard chemo-radiation based therapy. Molecular targeted medicines are currently seen as the next natural step in enhancing cervical cancer patient’s prognosis.[5] HER-2/neu expression in cervix lesion can help in the innovative therapeutic approaches and can be used as a guide to targeted therapies in case of carcinoma cervix. The expression of HER-2/neu in carcinoma cervix and their relationship with disease stage, grade and response to treatment is not well established in the current literature and very few studies have been conducted in this aspect. This study is undertakento determine the expression of HER-2/neu in pre malignant and malignant lesions of uterine cervix. |