Autotaxin (ATX) as a Marker for Breast Cancer

NCT04328194 | Unknown

• 1 other identifier: medicin
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Breast cancer is the leading cause of cancer death in women worldwide. According to the GLOBOCAN 2018 worldwide estimates of cancer incidence and mortality, in 2018, about 2,088,849 new cases were diagnosed and approximately 626,679 women were predicted to die from the disease . It is the leading cause of cancer related mortality, representing15% of deaths per year worldwide .

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• To estimate the level of serum ATX as a diagnostic marker for breast cancer.

  blood sample will be taken from the patients for measure of serum ATX

  Baseline (before any treatment)

Secondary Outcomes (1)

• To establish a cut off for serum ATX as a marker for breast cancer

  Baseline (before any treatment)

Study Arms (2)

Study Group

EXPERIMENTAL

80 patients with breast cancer

Diagnostic Test: Serum Autotaxin; Radiation: chest x-ray; Diagnostic Test: Breast ultrasound or mammography; Diagnostic Test: Histopathological examination of breast mass specimens; Radiation: Magnetic Resonance Imaging ( MRI) and Bone scan; Diagnostic Test: Peripheral haemogram; Diagnostic Test: Renal and liver functions; Diagnostic Test: Prothrombin time and concentration; Diagnostic Test: Cancer Antigen 15-3 (CA15-3).; Other: Full medical history; Other: Full clinical examination

Control Group

PLACEBO COMPARATOR

20 healthy controls aged ( 19 to 69 years ) from healthy volunteers after informed consent.

Diagnostic Test: Serum Autotaxin; Diagnostic Test: Cancer Antigen 15-3 (CA15-3).; Other: Full medical history; Other: Full clinical examination

Interventions

Serum Autotaxin DIAGNOSTIC_TEST

Marker

Control Group; Study Group

chest x-ray RADIATION

chest x- ray will be done for the study group

Study Group

Breast ultrasound or mammography DIAGNOSTIC_TEST

Breast ultrasound or mammography will be done for the study group to diagnosis of breast cancer

Study Group

Histopathological examination of breast mass specimens DIAGNOSTIC_TEST

by True cut or fine needle aspiration cytology

Study Group

Magnetic Resonance Imaging ( MRI) and Bone scan RADIATION

will be done for the study group

Study Group

Peripheral haemogram DIAGNOSTIC_TEST

blood sample will be taken from the patients

Study Group

Renal and liver functions DIAGNOSTIC_TEST

to exclude any other morbidity

Study Group

Prothrombin time and concentration DIAGNOSTIC_TEST

blood sample will be taken from the patients

Study Group

Cancer Antigen 15-3 (CA15-3). DIAGNOSTIC_TEST

will be done for the 2 groups

Control Group; Study Group

Full medical history OTHER

full medical history will be taken from all patients

Control Group; Study Group

Full clinical examination OTHER

full clinical examination will be done for the patients

Control Group; Study Group

Eligibility Criteria

• Age: 19 Years - 69 Years
• Gender Eligibility Details: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study will be conducted on one hundred female individuals; 80 newly diagnosed breast cancer patients before any treatment or surgical intervention and 20 apparently normal female individuals.

You may not qualify if:

• Patients with any other type of malignant or benign tumors, renal failure, cardiovascular diseases and liver cirrhosis were excluded from our study.
• Past history of chemotherapy or surgical treatment of any malignancy.
• Inflammatory diseases (e.g.bronchitis) or autoimmune diseases (e.g.rheumatoid arthritis).

Sponsors & Collaborators

• Assiut University: lead

Related Publications (24)

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

X-Rays; Ultrasonography, Mammary; Mammography; Magnetic Resonance Spectroscopy; Prothrombin Time

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Radiography; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Hanan Hareth, MD

CONTACT

01002954322; abdlatif@aun.edu.eg

Tahra Sherif

CONTACT

01227446166; tahrasherif@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 28, 2020
• First Posted: March 31, 2020
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: November 1, 2022
• Last Updated: March 31, 2020

Record last verified: 2020-03