| CTRI Number |
CTRI/2024/08/072342 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Awareness on symptoms and risk factors of ovarian cancer in women |
|
Scientific Title of Study
|
Awareness on symptoms and risk factors of ovarian cancer in women of north-urban Bengaluru |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Surabhi Sai PR |
| Designation |
PG Scholar |
| Affiliation |
K S Hegde Medical Academy, Nitte (Deemed to be University) |
| Address |
Department of Public Health, K S Hegde Medical Academy, Nitte (Deemed to be university), Derallakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575108
India |
| Phone |
7259014239 |
| Fax |
|
| Email |
surabhispr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Surabhi Sai PR |
| Designation |
PG Scholar |
| Affiliation |
Nitte (Deemed to be University) |
| Address |
#352, 5th main, 1st cross canara bank layout kodigehalli, Bengaluru
KARNATAKA
560097
India |
| Phone |
7259014239 |
| Fax |
|
| Email |
surabhispr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Surabhi Sai PR |
| Designation |
PG Scholar |
| Affiliation |
K S Hegde Medical Academy, Nitte (Deemed to be University) |
| Address |
Department of Public Health, K S Hegde Medical Academy, Nitte (Deemed to be University), Mangaluru
Dakshina Kannada
KARNATAKA
575108
India |
| Phone |
7259014239 |
| Fax |
|
| Email |
surabhispr@gmail.com |
|
|
Source of Monetary or Material Support
|
| K S Hegde Medical Academy, Nitte(Deemed to be University), Mangaluru, 575108 |
|
|
Primary Sponsor
|
| Name |
Surabhi Sai PR |
| Address |
KS Hedge Medical Academy, Nitte university- 575108 |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 Mackwin Dmello |
K S Hegde Medical Academy, Nitte (Deemed to be University) |
K S Hegde Medical Academy, Nitte (Deemed to be University), Mangaluru, 575108
Dakshina Kannada
KARNATAKA |
9844460590
mackwin@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K S Hegde Medical Academy, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Ovarian Cancer |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Women of age group 18-65 years. |
|
| ExclusionCriteria |
| Details |
Women aged 18-65 years with personal history of ovarian cancer or who have undergone salpingo-oophorectomy or hysterectomy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean awareness score of ovarian cancer, its symptoms and risk factors |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Factors associated with the awareness of ovarian cancer symptoms and risk factors |
2 months |
|
|
Target Sample Size
|
Total Sample Size="375"
Sample Size from India="375"
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)
|
24/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/08/2024 |
| 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 Yet Recruiting |
| 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
|
Ovarian cancer was reported as the third most prevalent cancer among Indian women and ranked eighth overall, constituting 3.44% (36,170 cases) of all cancer instances according to the 2018 Globocan Fact sheet (13). It also stood as a leading cause of cancer-related deaths in Indian women, accounting for 3.34% (24,015 deaths) of all cancer fatalities in the same year (ICMR). Among 28 Population-Based Cancer Registries, ovarian cancer featured in the top ten cancers. Over the years from 1984 to 2014, there has been a consistent rise i.e., from approximately four to eight cases per 100,000 of the population in ovarian cancer rates, particularly notable in Bangalore and Bhopal (26). Despite being less common than other gynecological malignancies like cervical cancer, ovarian cancer’s high mortality is attributed to late-stage detection. Improving mortality rates necessitates a focus on prevention, screening, early detection, and optimal management. Due to low awareness about ovarian cancer and its symptoms, most women are diagnosed at advanced stages. Given that the prognosis and survival rates depend significantly on the disease’s stage at diagnosis, it is crucial to raise awareness about the symptoms and the disease itself. Therefore, this study aims to find the awareness among women about ovarian cancer, its symptoms, and risk factors |