Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310882
Status:
WITHDRAWN
Last Update Posted:
2011-04-08
First Post:
2006-04-04
Brief Title:
Involvement of Endogenous Digitalis-like Compounds in Breast Cancer
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
Involvement of Endogenous Digitalis-like Compounds in Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
the PI is no longer work at Hadassah
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The endogenous digitalis-like compounds DLCare steroid hormones synthesized and released from the adrenal glandThey are integrated in the feed-back system of the Hypothalami-Pituitary-Adrenal gland axisOne of their remarkable function is to induce apoptosis in malignant cells Recently accumulating data point to the possibility of using synthetic DLC as new anti-cancer drugs Less is known about the endogenous metabolism of these compounds in cancer patients
Proceeding from preliminary clinical data which demonstrated significantly reduced DLC plasma levels in breast cancer patients and from in vitro data which showed an impaired release of DLC towards stress stimuli in athymic nude micewe put up the hypothesis that a latent adrenal insufficiency with low DLC levels facilitates the induction and progression of tumor diseases
Proceeding from preliminary clinical data which demonstrated significantly reduced DLC plasma levels in breast cancer patients and from in vitro data which showed an impaired release of DLC towards stress stimuli in athymic nude micewe put up the hypothesis that a latent adrenal insufficiency with low DLC levels facilitates the induction and progression of tumor diseases
Detailed Description:
To pursue this question about endogenous DLC metabolism in cancer patients we intend to start with the measurement of DLC plasma levels in breast cancer patients at the time of first diagnosis and compare them to women with benign breast disease as well as healthy women
Aim of the Study
To evaluate the basal DLC plasma concentrations in cancer patients at the time of first diagnosis and the function of the HPA axis with focussing on breast cancer patients
To analyze a potential change of HPA function and in parallel DLC plasma concentrations in the course of therapy with special respect to treatment failure
To establish a potential correlation between DLC plasma concentrations and risk factors in BC
Patients and Methods
Patients
I 50 - 100 patients with breast cancer at the time of first diagnosis
II 50 - 100 patients with a benign disease of the breast
III 50 - 100 women undergoing plastic surgery of the breast
IV 50 - 100 women who need no further exploration after visit in ambulance normal population
V additionally a group of 25 - 50 students age 20-40 will be analyzed in a pilot study
Methods
Time-schedule for Group I Group II - IV alike according to disease andor situation
Day of first presentation of the woman at the clinic
Day of first diagnosis ie biopsyFNA
Day of start of treatment operation chemo-radiotherapy tst 0
Day 30 60 90
6 month and 1 year after start of treatment
The Group V students will be analyzed in a special schedule preceding the study 1-2 months
4 weeks before an important exam
a day before the exam -3 days
a day after the exam 3 days
2 weeks after the exam
6 weeks after the exam
Parameters
Biochemistry Group I - V
Basal DLC plasma concentration
Basal serum Cortisol concentration
Basal plasma ATCH concentration
Basal AldosteroneRenin concentration
Electrolytes potassium sodium calcium chloride
PathologyImmunohistochemistry Group I II when benign including last 4 points
Tumor size
lymph node status
EP receptors
Grade
HER2neu
Bcl-2
Ki67
p53
Radiology Group I
If abdominal CT available measurement of size of the adrenal glands
Endocrinologic tests Group I - IV
Dexamethasone-test low dose
2 mg Dexamethasone po at 2400
measurement of Cortisol and DLC at 800 the next morning
ACTH-test
basal plasma concentrations of Cortisol DLC and ACTH
administration of 250 µg ACTH Synachten iv
measurement of Cortisol and DLC after 30 min and 60 min
Facultative Metapyrone test
at following time intervals
1 Dexamethasone-test
around the time of first presentation 5 days
around the time of start of treatment 5 days corresponding times for Group II- IV
Day 30 60 90
6 month and a year after start of treatment
2 ACTH-test
On the day of first presentation
On the day of start of treatment corresponding times for Group II- IV
Day 30 60 90
6 months and one year after start of treatment
Psychometric test for Stress Evaluation Group I - V
at the day of first presentation Students in between the last 2 weeks before an exam
at the end of the study
Aim of the Study
To evaluate the basal DLC plasma concentrations in cancer patients at the time of first diagnosis and the function of the HPA axis with focussing on breast cancer patients
To analyze a potential change of HPA function and in parallel DLC plasma concentrations in the course of therapy with special respect to treatment failure
To establish a potential correlation between DLC plasma concentrations and risk factors in BC
Patients and Methods
Patients
I 50 - 100 patients with breast cancer at the time of first diagnosis
II 50 - 100 patients with a benign disease of the breast
III 50 - 100 women undergoing plastic surgery of the breast
IV 50 - 100 women who need no further exploration after visit in ambulance normal population
V additionally a group of 25 - 50 students age 20-40 will be analyzed in a pilot study
Methods
Time-schedule for Group I Group II - IV alike according to disease andor situation
Day of first presentation of the woman at the clinic
Day of first diagnosis ie biopsyFNA
Day of start of treatment operation chemo-radiotherapy tst 0
Day 30 60 90
6 month and 1 year after start of treatment
The Group V students will be analyzed in a special schedule preceding the study 1-2 months
4 weeks before an important exam
a day before the exam -3 days
a day after the exam 3 days
2 weeks after the exam
6 weeks after the exam
Parameters
Biochemistry Group I - V
Basal DLC plasma concentration
Basal serum Cortisol concentration
Basal plasma ATCH concentration
Basal AldosteroneRenin concentration
Electrolytes potassium sodium calcium chloride
PathologyImmunohistochemistry Group I II when benign including last 4 points
Tumor size
lymph node status
EP receptors
Grade
HER2neu
Bcl-2
Ki67
p53
Radiology Group I
If abdominal CT available measurement of size of the adrenal glands
Endocrinologic tests Group I - IV
Dexamethasone-test low dose
2 mg Dexamethasone po at 2400
measurement of Cortisol and DLC at 800 the next morning
ACTH-test
basal plasma concentrations of Cortisol DLC and ACTH
administration of 250 µg ACTH Synachten iv
measurement of Cortisol and DLC after 30 min and 60 min
Facultative Metapyrone test
at following time intervals
1 Dexamethasone-test
around the time of first presentation 5 days
around the time of start of treatment 5 days corresponding times for Group II- IV
Day 30 60 90
6 month and a year after start of treatment
2 ACTH-test
On the day of first presentation
On the day of start of treatment corresponding times for Group II- IV
Day 30 60 90
6 months and one year after start of treatment
Psychometric test for Stress Evaluation Group I - V
at the day of first presentation Students in between the last 2 weeks before an exam
at the end of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None