| CTRI Number |
CTRI/2026/04/107398 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to see if chemicals from plastic products are related to ovarian cancer in women |
|
Scientific Title of Study
|
Association of phthalates with primary ovarian cancer |
| 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 Begum Jazia A |
| Designation |
PG resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Biochemistry Pathology Block Maulana Azad Medical College Bahadur Shah Zafar Marg Central Delhi
Central
DELHI
110002
India |
| Phone |
8132074701 |
| Fax |
|
| Email |
drjazia2126@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anubhuti |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Biochemistry Pathology Block Maulana Azad Medical College Bahadur Shah Zafar Marg Central Delhi
Central
DELHI
110002
India |
| Phone |
9999323592 |
| Fax |
|
| Email |
anubhutimamc2025a@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anubhuti |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Biochemistry Pathology Block Maulana Azad Medical College Bahadur Shah Zafar Marg Central Delhi
Central
DELHI
110002
India |
| Phone |
9999323592 |
| Fax |
|
| Email |
anubhutimamc2025a@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College
Bahadur Shah Zafar New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Department of Biochemistry Pathology Block Maulana Azad Medical College Bahadur Shah Zafar New Delhi-110002 |
| Type of Sponsor |
Government 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 Begum Jazia A |
Maulana Azad Medical College |
Room no 205 2nd floor Department of Biochemistry Pathology Block Maulana Azad Medical College New DELHI
Central
DELHI |
08132074701
drjazia2126@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospital(Lok Nayak, G.I.P.M.E.R, Guru Nanak Eye Centre, New Delhi-110002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
For Cases: Females with radiologically and biochemically proven primary ovarian cancer scheduled for surgery, with diagnosis to be subsequently confirmed by histopathological examination.
For Controls: Apparently age matched healthy females, mainly attendants of the patients |
|
| ExclusionCriteria |
| Details |
1. Presence of chronic illness
2. Patients living in areas with occupational hazards
3. Pregnant and lactating females
4. Females currently undergoing cancer treatment
5. Females diagnosed with other malignancies
6. Female with hormone-dependent conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Mean difference of DEHP and MEHP levels in the urine of females diagnosed with primary ovarian cancer and age-matched healthy females.
2.The correlation of DEHP/MEHP levels with changes in ovarian cancer cell proliferation rate and migration distance along with transformation of normal ovarian cell line into cancer cell line. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
06/04/2026 |
| 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
|
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 aims to assess whether exposure to phthalates, commonly used plasticizers, is associated with primary ovarian cancer. Urinary levels of di(2-ethylhexyl) phthalate (DEHP) and its metabolite will be compared between women with ovarian cancer and age-matched healthy women. Laboratory studies will also evaluate the effects of these chemicals on ovarian cancer cell growth and migration. The study will be conducted after ethics approval and informed consent at Maulana Azad Medical College and associated hospitals. |