Active Monitoring for Ductal Carcinoma in Situ

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Bozeman Health, Bozeman, MT
Ductal Carcinoma in Situ+4 More
Active Monitoring - Other
Eligibility
18+
Female
What conditions do you have?
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Study Summary

This study is evaluating whether active monitoring is as effective as surgery for low-risk DCIS.

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Eligible Conditions

  • Ductal Carcinoma in Situ
  • DCIS

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Active Monitoring will improve 1 primary outcome, 13 secondary outcomes, and 17 other outcomes in patients with Ductal Carcinoma in Situ. Measurement will happen over the course of Baseline.

Year 7
Breast MRI utilization rate
Breast biopsy rate
Breast cancer specific survival rate
Breast conservation rate
Chemotherapy rate
Contralateral invasive cancer rate
Mastectomy rate
Overall survival rate
Radiation rate
Year 7
Ipsilateral invasive cancer rate in AM arm
Ipsilateral invasive cancer rate in surgery arm at 5 and 7 year follow-up
6 months
Financial burden
Year 2
Adherence to hormonal therapy
Self-reported co-morbidity
At 2 years follow-up
Proportion of new diagnoses of ipsilateral invasive cancer in surgery and AM arms at 2 years of follow up
Baseline
Communication with physicians
Coping
Baseline and 2 years
Concerns about future breast events
Knowledge
Risk perceptions
Year 2
Intolerance of uncertainty
Year 2
Body image
Breast specific pain
General pain
Generalized Depression
Generalized anxiety
Psychological outcomes
Quality of Life (QOL)
Symptoms
Year 1
Employment status
Years 1 through 5
Decisional regret

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Surgery
1 of 2
Active Monitoring
1 of 2
Active Control
Experimental Treatment

This trial requires 1200 total participants across 2 different treatment groups

This trial involves 2 different treatments. Active Monitoring is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Active Monitoring
Other
DCIS - Choice for endocrine therapy (MMG q 6 months x 5 years GCC for invasive progression)
Surgery
Other
DCIS - Surgery +/- radiation choice for endocrine therapy (MMG q 12 months x 5 years usual care for recurrent disease)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2, 5, and 7 year follow-up
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2, 5, and 7 year follow-up for reporting.

Closest Location

Bozeman Health - Bozeman, MT

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Diagnosis of unilateral, bilateral, unifocal, multifocal, or multicentric DCIS without invasive breast cancer (date of diagnosis defined as the date of the first pathology report that diagnosed the patient with DCIS) OR: atypia verging on DCIS OR: DCIS + LCIS (mix and/or separate locations in the same breast)
A patient who has had a lumpectomy or partial mastectomy with margins positive for DCIS (i.e. <2mm/ink on tumor) as part of their treatment for a current DCIS diagnosis is also eligible (post-excision bilateral mammogram required at enrollment to establish a new baseline)
No previous DCIS or invasive breast cancer in ipsilateral breast 5 years prior to current DCIS diagnosis
40 years of age or older at time of DCIS diagnosis
ECOG performance status 0 or 1
No contraindication for surgery
Unilateral DCIS: contralateral normal mammogram ≤ 6 months of registration and ipsilateral breast imaging ≤ 120 days of registration (must include ipsilateral mammogram; can also include ultrasound or breast MRI)
Bilateral DCIS: bilateral breast imaging ≤ 120 days of registration (must include bilateral mammogram; can also include ultrasound or breast MRI)
DCIS s/p lumpectomy: post excision mammogram on side of excision ≤ 60 days of registration
Any grade I DCIS (irrespective of necrosis/comedonecrosis)

Patient Q&A Section

What is carcinoma in situ?

"CIS is a precancerous condition of the urethra, vulva and penis. The most common site is the penis, accounting for 70% of cases, followed by the urethra (20%) and the vulva (10%). The condition is often asymptomatic. Histologically, it is a metaplastic change of urothelial cells. The term is from the Latin terminology 'carcinomatous in situ' and means 'in situ carcinoma'. The neoplastic transformation takes place in either vulval or penile urothelium. The presence of the neoplastic change at the time of biopsy is essential to make a diagnosis." - Anonymous Online Contributor

Unverified Answer

What are the signs of carcinoma in situ?

"Recent findings emphasize the need for a detailed biopsy of suspicious lesions in order to identify CIS and provide staging and treatment information that would improve the long-term prognosis. Therefore, an important and routine biopsy is advocated for any lesions found on HSIL or HSIL+CIN, in particular for those with a high probability of invasive SCC requiring extensive surgical resection." - Anonymous Online Contributor

Unverified Answer

How many people get carcinoma in situ a year in the United States?

"The incidence of CCS, as reported by the SEER database, appears to be close to the overall incidence of invasive carcinoma in females. A substantial proportion, however, of these CCS appears not to have been detected by the usual means. We estimate that up to one in four invasive carcinomas detected in the United States could have been in situ at diagnosis." - Anonymous Online Contributor

Unverified Answer

Can carcinoma in situ be cured?

"Although the incidence of carcinoma in situ in this population is low (0.07%) it is a well-known fact that all cases with precancerous changes (carcinoma in situ) cannot be cured. However, thanks to modern developments in cancer screening it is now possible to identify those women who are going to develop invasive cancer. Current research is currently focused on determining the risk and effectiveness of screening for carcinoma in situ in patients at risk for cervical intraepithelial neoplasia (CIN) type." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma in situ?

"Treatment of cervical carcinoma in situ are highly dependent on the characteristics of the individual. Larger, high grade lesions require more extensive surgical excision. Tissue margins and lymph nodes are not always affected by the treatment plan. It is unlikely that there is a treatment option for most patients with carcinoma in situ of the cervix." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma in situ?

"The cause of carcinoma in situ remains unclear. One explanation that is gaining traction is that it arises from a lesion of the epithelial basal layer which lacks adequate amounts of epithelial permeability due to loss of tight junctions. This lesion is a result of reduced cell proliferation, loss of cell layer cohesion and increased levels of cellular permeability. If the lesion occurs in the anogenital region, the cause could be related to the action of estrogen, which prevents the epithelial cell proliferation and induces further epithelial changes during puberty." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating carcinoma in situ?

"Patients with carcinoma in situ are more difficult to manage than conventional epithelial carcinomas. However, they can be treated effectively using modern chemotherapeutic agents and radiation. Patients with carcinoma in situ should continue to receive these treatments because they are effective at prolonging survival." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets carcinoma in situ?

"Carcinoma in situ that has not spread beyond the cervix and uterus does not affect survival. Treatment decisions are therefore not influenced by the location of the disease." - Anonymous Online Contributor

Unverified Answer

Is active monitoring typically used in combination with any other treatments?

"Cancers treated with surgery and radiation therapy were most often treated using active monitoring. Only one or two treatments were received by patients who did not undergo active monitoring. Whether or not active monitoring is effective for preventing recurrence of cancers from which the patient had previously survived remains to be determined." - Anonymous Online Contributor

Unverified Answer

How quickly does carcinoma in situ spread?

"In a recent study, findings show an increased rate of local recurrence of CIC. Early detection of CIC is therefore important. There is no evidence for a higher rate of CIS metastasis in the elderly." - Anonymous Online Contributor

Unverified Answer

How does active monitoring work?

"Although most women were satisfied after surgery and were generally satisfied with the outcome of the intervention, the majority of study participants were exposed to some risks associated with cancer follow-up and are likely to continue to be exposed to them throughout their survivorship. For many women, the most salient risk may be the psychological distress and burden associated with anxiety and distress related to the follow-up activities." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for carcinoma in situ?

"Based on the results of this analysis of 1251 patients with CIS, the 2-year and 25-year survival rates appear to be excellent and have not significantly changed over time." - 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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