Treatment for Carcinoma, Ductal

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Diagnostic Center for Women, Miami, FL
Carcinoma, Ductal+4 More
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether cryoablation is a feasible treatment for breast DCIS.

See full description

Eligible Conditions

  • Carcinoma, Ductal
  • Ductal Carcinoma in Situ

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome in patients with Carcinoma, Ductal. Measurement will happen over the course of 2 years.

2 years
complete tumor ablation

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

0 Treatment Group

This trial requires 20 total participants across 0 different treatment group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Who is running the study

Principal Investigator
M. P.
Michael Plaza, Principal Investigator
Larkin Community Hospital

Closest Location

Diagnostic Center for Women - Miami, FL

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Tumor size < 1.5 cm in greatest diameter. Specifically, the tumor must measure < 1.5 cm in the axis parallel to the treatment probe and < 1.5 cm in the axis anti-parallel to the treatment probe. Largest size measured by required pre-treatment scans (mammogram, ultrasound and MRI) will be used to determine eligibility.
Age >= 18
Unifocal primary ductal carcinoma in situ (DCIS) or atypical ductal hyperplasia (ADH) bordering on DCIS or DCIS with microinvasion diagnosed by core needle biopsy. NOTE: Patients with lobular carcinoma, multifocal and/or multicentric ipsilateral breast cancer are NOT eligible. Patients with contralateral disease will remain eligible.
Ultrasound-visible mass or nonmass finding corresponding to the tumor or An ultrasound-visible biopsy marker placed within 1cm of the biopsied tumor.
No prior or planned neoadjuvant chemotherapy for breast cancer.
Adequate breast size for safe cryoablation. This will be determined by the interventional radiologist using a combination of clinical exam and imaging. Site of target for cryoablation must be greater than 1 cm from the nipple and greater than 1cm from the closest skin surface.

Patient Q&A Section

What is carcinoma in situ?

"Data from a recent study demonstrates that CIS is not a single entity but rather a heterogeneous group of tumors with different malignant potentials and outcomes. The findings may benefit cancer prevention strategies for women with CIS." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of treatment?

"This analysis shows that there are many common side effects associated with systemic steroid therapy. Findings from a recent study suggest that it may be beneficial to monitor patients regularly while on systemic steroid therapy, especially those who are taking corticosteroids for long periods of time." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in treatment for therapeutic use?

"In view of the increasing number of patients with early stage disease treated surgically, radiotherapy has become less important than it once was. Patients with resectable tumors should now receive adjuvant radiotherapy (when possible) if they were previously thought to only benefit from surgery. However, even when colorectal surgeons are confident that an adequate surgical resection has been achieved, a patient who has invasive carcinoma in situ will not always require adjuvant radiotherapy as long as the patient is being followed up regularly and carefully." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for carcinoma in situ?

"Results from a recent clinical trial suggest that women should be considered for adjuvant therapies, especially if they have a positive surgical margin. Women with negative margins might benefit from adjuvant treatment as well." - Anonymous Online Contributor

Unverified Answer

Is treatment typically used in combination with any other treatments?

"Nearly all patients received treatment in combination with another treatment; the information presented here suggests that the most common combination is chemotherapy followed by radiotherapy." - Anonymous Online Contributor

Unverified Answer

What is the latest research for carcinoma in situ?

"Diabetes mellitus was associated with increased risk for CIS lesions. The association between smoking and CIS remains controversial. There is some evidence suggesting that women who have had previous pregnancies are at higher risk for CIS. The latest research suggests that there is no significant difference between men and women regarding the occurrence of primary neoplasia after the age of 50." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets carcinoma in situ?

"The median age of men with CIS was 63 years (range 48-85 years) and the median age of women was 68 years (range 49-84 years). A total of 3,458 men and 1,716 women were included in this cohort. Findings from a recent study are consistent with previous publications reporting the prevalence of CIS in this population." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for carcinoma in situ?

"The 5-year survival rate for women diagnosed with CIS was 80% while for men it was 58%. Survival rates were higher for younger patients compared to older patients. There was also a correlation between high grade DCIS and worse outcome. The survival rate for low grade DCIS was similar to that for non-DCIS CIS. The 5-year survival rate was 34% for invasive breast cancer." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of carcinoma in situ?

"In our experience, CIS was diagnosed in 9% of women over 55 years of age. It was associated with HPV infection and an increased risk of malignant transformation (3.3 times) compared with non-CIS CIS." - Anonymous Online Contributor

Unverified Answer

How does treatment work?

"There was no significant association between treatment (chemotherapy and radiation therapy) and survival in our cohort of patients with CIS. However, treatment is associated with improved disease control, indicating that chemotherapy and radiation therapy have some benefit for this particular subset of patients." - Anonymous Online Contributor

Unverified Answer

Does treatment improve quality of life for those with carcinoma in situ?

"Although not statistically significant, more respondents reported that they had improved QOL due to treatment. Because of the small sample size, larger studies should be conducted to confirm these findings." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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