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Clinical Trials/CTRI/2017/10/010115
CTRI/2017/10/010115
Completed
未知

Multicentric Study to evaluate the effectiveness of Thermalytix© (automated thermographic screening algorithms developed by NIRAMAI) as compared to standard screening modalities in subjects who show possible symptoms of suspected breast cancer - SANT17

IRAMAI Health Analytix Pvt Ltd0 sites258 target enrollmentTBD
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ConditionsHealth Condition 1: C509- Malignant neoplasm of breast of unspecified siteHealth Condition 2: R688- Other general symptoms and signsHealth Condition 3: null- possible symptoms of suspected breast cancer

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: C509- Malignant neoplasm of breast of unspecified siteHealth Condition 2: R688- Other general symptoms and signsHealth Condition 3: null- possible symptoms of suspected breast cancer
Sponsor
IRAMAI Health Analytix Pvt Ltd
Enrollment
258
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
July 31, 2018
Last Updated
4 years ago
Study Type
Observational

Investigators

Sponsor
IRAMAI Health Analytix Pvt Ltd

Eligibility Criteria

Inclusion Criteria

  • •1\. Female subjects equal to and above 18 years presenting with the following breast abnormalities:
  • •(1a) Palpable lump, swelling or mass in breast
  • •(1b) Persistent breast pain or tenderness that is unrelated to menstrual cycle
  • •(1c) Nipple is inverted or tender, painful, scaly or with discharge (clear or bloody)
  • •(1d) Skin on breast is dimpled, red, blotchy, pricking, itchy or has change in the texture
  • •(1e) Increase in breast size that is not related to menstrual cycle
  • •(1f) Thickening in or around the breast or underarm area
  • •(1g) Or any other symptoms leading to suspicion of breast cancer
  • •2\. Subjects who are willing to give written informed consent for study participation
  • •3\. Subjects who are ready to comply with the study related visits and procedures

Exclusion Criteria

  • •1\. Subjects who are pregnant
  • •2\. Subjects who are lactating
  • •3\. Subjects who have undergone either lumpectomy or mastectomy
  • •4\. Subjects who have undergone Chemotherapy in the last 2 weeks at the time of study enrollment
  • •5\. Any active illness, psychological and/or pathological condition that would interfere with study participation in the opinion of the Investigator

Outcomes

Primary Outcomes

Not specified

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