Wounds and Injuries

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Carcinoma In Situ

Carcinoma

Carcinoma in Situ

Breast Diseases

Skin Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients in Arm A undergo simplex mastectomy or modified radical mastectomy. One plastic Redon drain (16 Ch) is placed after simplex mastectomy and two plastic Redon drains (16 Ch each) following modified radical mastectomy.

Following mastectomy, wound cavity is closed with adaptive skin sutures. No suction drain is inserted.

One suction drain (16 Ch Redon drain) following simple mastectomy and two following modified radical mastectomy.

Insertion of suction drain(s) following mastectomy

Subcutis of skin flaps of the axilla and the wound edges are adapted to the chest wall and pectoralis major muscle by 8 to 24 stitches (depending on the wound surface of the breast and axilla) using 3.0 absorbable sutures, in a distance of 4-5 cm from each other in a chessboard pattern. The wound is then closed with 3.0 running subcutaneous sutures and 4.0 intracutaneous stitches. Compressive dressing is applied on the chest in the first 12-24 hours after surgery.

Adaptive skin sutures.

Zoltan Matrai, M.D.

Laszlo Toth, M.D., Ph.D.

Miklos Kasler, M.D., Ph.D., D.Sc., Prof.

Laszlo Toth, M.D., Ph.D., Prof.

Ferenc Renyi Vamos, M.D., Ph.D.

Akos Savolt, M.D.

Emil Farkas, M.D.

Ildiko Horti, M.D.

The objective of this prospective randomized study is to perform qualitative and quantitative comparisons between the insertion of traditional suction drains (Arm: Suction drain) versus the application of absorbable adaptive sutures (Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.

Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study

Optimal Wound Care After Simplex or Modified Radical Mastectomy With or Without Axillary Lymphadenectomy Placement of a Drain Versus the Use of Adaptive Skin Sutures; a Prospective Randomised Study

By each follow-up visit within the indicated time frame, the punctuated serum is collected and its volume is measured by a measuring cylinder acquired from the Pharmacy Department and data is recorded. At the end of the follow-up period, the total amount of serum (mL) is documented.

Assessment of analgesic consumption to achieve adequate pain relief for each patient. Pain relief is carried out according to institutional protocol and includes: diclofenac sodium, diclofenac sodium + orphenadrine, nalbuphine, metamizole sodium, paracetamole, tramadole.

Using EORTC QoL BR23, weekly for 4 weeks following surgery.

Assessing shoulder motion on the 1st postoperative day, then weekly for 4 weeks.

Abduction 1: 0°- 45° Abduction 2: 45° - 90° Abduction 3: 90° - 135° Abduction 4: 135° - 180°

Suction drain, suction flask, syringes, number of patient-doctor consultations

National Institute of Oncology, Hungary

principal investigator

radio-labelled (I-125) titanium seed inserted via needle into nonpalpable breast lesion and gamma probe used to guide surgery

radioguided seed localization for nonpalpable breast cancers

Peter J Lovrics, MD

Mary Townsend

The purpose of this study is to determine whether a new surgical technique (radioguided seed localization) for localizing nonpalpable breast tumours is better than the standard technique (needle localization).

Most breast cancers are removed by partial mastectomy/lumpectomy. The most important factor in ensuring that the cancer does not return in the breast is to ensure that it is completely removed during surgery. Complete removal is dependent on having a rim of normal tissue (clear margin) surrounding the cancer. If the margin is positive, or the cancer recurs, more surgery or mastectomy is required. Approximately one third of breast cancers are detected by mammograms or ultrasounds and cannot be felt by patients or physicians. Accordingly, a localization technique is required to help the surgeon to find and remove the cancer. The current technique (needle localization) has a higher chance of having cancer cells at the margin. This is a study about a surgical technique. The objective of this comparison study is to determine whether a new technique (radioguided seed localization) is a better way to remove nonpalpable breast cancers. The main objective of this study is to determine if the new technique generates fewer positive margins compared to the standard technique. An improved technique would benefit thousands of women every year.

Trial Comparing Radioactive Seed Localization to Standard Procedure for Non-palpable Breast Cancers

A Prospective, Randomized, Controlled Trial of Radioguided Seed Localization Versus Standard Needle Localization of Nonpalpable Breast Cancers

Canadian Breast Cancer Foundation

McMaster University

Dr. Peter J. Lovrics

The research study procedures include screening for eligibility and study interventions including evaluations and follow up visits - After receiving genetic testing, participants will be placed into one of two counseling methodology groups:

-- Quantitative genetic counseling: Discussion is guided by tables and graphs.

The research study procedures include screening for eligibility and study interventions including evaluations and follow up visits - After receiving genetic testing, participants will be placed into one of two counseling methodology groups:

-- Standard genetic counseling: Standard of care discussion

Standard genetic counseling: Standard of care discussion

Standard Genetic Counseling

Quantitative genetic counseling: Discussion is guided by tables and graphs.

Quantitative Genetic Counseling

Tara King, MD

This study is designed to determine the impact of a novel genetic counseling method on surgical decisions in individuals with newly diagnosed breast cancer

This research study involves an expedited and surgery-specific form of genetic counseling.

The names of the study methods involved in this trial are/is:

* Quantitative genetic counseling (discussion is guided by tables and graphs)
* Standard genetic counseling

* The research study procedures include screening for eligibility and study interventions including evaluations and follow up visits
* After receiving genetic testing, participants will be placed into one of two counseling methodology groups:

  * Standard genetic counseling: Standard of care discussion
  * Quantitative genetic counseling: Discussion is guided by tables and graphs.
* Participants will be on the research study for up to six months, with an optional extension to two years.
* It is expected that about 450 people will participate.
* This research study is a Feasibility Study, which is the first-time investigators are examining this form of genetic counseling.
* This is a randomized study. Randomization means being put into a group by chance. It is like flipping a coin. Neither the participant nor the Investigator will choose the group the participant is assigned to.

Genetic Testing for All Breast Cancer Patients (GET FACTS)

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

A short survey, self-developed in conjunction with the Dana Farber Cancer Institute professional survey core, will be used to compare changes in patients' personal contralateral breast cancer (CBC) risk assessment after quantitative versus standard genetic counseling. The question reads: "By the time you turn 80 years old, what do you believe is the chance you will develop cancer in the other (unaffected) breast?" and answer options are in 10% increments (ie. 0-10%, 11-20%, 21-30%). Their individual assessment of their risk will be collected before and after genetic counseling and will be compared to CBCRisk (for those without gene mutations) or ASK2ME (for those with gene mutations).

Patient's will be surveyed about their personal propensity to choose a bilateral mastectomy as the surgical treatment of a unilateral cancer before and after quantitative vs. standard counseling. This survey question was self-developed in conjunction with the Dana Farber Cancer Institute professional survey core. The question reads: "How likely or unlikely are you to choose surgery to remove both breasts (bilateral mastectomy) for your cancer in one breast (unilateral or one-sided breast cancer)?"s answer options include the following: "Very unlikely, Somewhat unlikely, Unsure (neither likely nor unlikely), Somewhat likely, Very likely).

Breast cancer patient satisfaction with genetic counseling practices,comparing the delivery of results by quantitative counseling versus standard counseling, as measured by the Genetic Testing Satisfaction Survey (GTS).

CPM rates will be measured and compared between patients who undergo quantitative versus standard genetic counseling.

Patients' level of anxiety will be compared between quantitative versus standard genetic counseling to monitor that we are avoiding undue stress on the patients. We will use the Patient-Reported Outcomes Information System (PROMIS) anxiety scale. Scores can range from 8-40, with 40 indicating worse anxiety.

Decisional regret will be measured and compared between quantitative versus standard genetic counseling, for both the decision to undergo genetic testing and the surgical choice that was made.

Myriad Genetics, Inc.

Dana-Farber Cancer Institute

Principal Investigator

Digestive System Diseases

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Stomach Neoplasms

Lymphoma

Urinary Bladder Neoplasms

Lymphoma, Mantle-Cell

Laryngeal Diseases

Laryngeal Neoplasms

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Lymphoma, Non-Hodgkin

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Otorhinolaryngologic Diseases

Stomach Cancer

Lymphosarcoma

Mantle Cell Lymphoma

The research study procedures include:

* Screening for eligibility
* Study treatment including evaluations
* MR-image guided radiation will be administered per disease site standards.
* Follow up visits
* Questionnaires

MR-image guided radiation will be administered per disease site standards.

Viewray MRIdian® Linac

Raymond Mak, MD

This research is being done to determine the safety and feasibility of using a type of radiation guided by magnetic resonance imaging (MRI) and chemotherapy to treat patients with gastric and breast cancer. The name of the radiation machine involved in this study is the MRIdian Linear Accelerator.

This is a master clinical protocol evaluating magnetic resonance (MR) image guided radiation in patients with gastric and breast cancer.

In this research study, the investigators are researching if getting an MRI during radiation is a feasible way to delivery radiation. In this research study, a MRI done during treatment will help doctors adapt the radiation to target the most precise spot where the cancer is located.

The research study procedures include:

* Screening for eligibility
* Study treatment including evaluations
* Follow up visits
* Questionnaires

This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of investigational radiation treatment and also tries to define the appropriate dose of the investigational radiation treatment to use for further studies. "Investigational" means that the way the radiation treatment is delivered is being studied.

This research study is a Feasibility Study, which means it is the first-time investigators at this institution are examining this type of MR-guided radiation. Investigators at other hospitals and academic centers are already using this type of radiation.

The U.S. Food and Drug Administration (FDA) has approved this radiation machine and these drugs as treatment options for gastric and breast cancer.

CONFIRM: Magnetic Resonance Guided Radiation Therapy

Clinical Onboard Utilization of Image Guided Radiation Therapy With Magnetic Resonance (CONFIRM): A Master Protocol

Master feasibility study evaluating MR-image guided radiation. Feasibility is defined as Enrolling patients and delivering MR-image guided radiation on the MR Linac

Master feasibility study evaluating MR-image guided radiation. Feasibility is defined as assessing tumor using MR guidance before, during and after MR-guided treatment patient.

PROMs are collected at patient visits. PROMs will be evaluated using the Patient-Reported Outcomes Measurement Information System (PROMIS). The PROMIS Global-10 metric collects information on symptoms and quality of life.

Tumor response 1 year after radiation treatment

full pathological review of surgical specimen according to the AJCC Staging Classification, 8th edition. pCR will be defined as the absence of any viable tumor cells within the pathologic specimen.

Toxicity of MRgRT with concurrent chemotherapy will be summarized by category and grade according to CTCAE version 5.0.

Total time of treatment for each fraction

Estimated using the Kaplan Meier method with 95% confidence intervals based on the complementary log-log transformation.

The OS rate will be estimated using the Kaplan-Meier method with 95% confidence intervals based on the complementary log-log transformation.

Evaluation of tumor response following treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study	NCT01509781	in Situ Breast ... Invasive Breast...	Insertion of su... Adaptive skin s...	- 75 Years	National Institute of Oncology, Hungary
Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study	NCT01509781	in Situ Breast ... Invasive Breast...	Insertion of su... Adaptive skin s...	- 75 Years	National Institute of Oncology, Hungary
Trial Comparing Radioactive Seed Localization to Standard Procedure for Non-palpable Breast Cancers	NCT00225927	Breast Cancer I... Stage 0 Breast ...	radioguided see...	18 Years -	McMaster University
Genetic Testing for All Breast Cancer Patients (GET FACTS)	NCT04245176	Breast Cancer Invasive Breast... in Situ Breast ... Genetic Testing	Standard Geneti... Quantitative Ge...	18 Years - 79 Years	Dana-Farber Cancer Institute
Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study	NCT01509781	in Situ Breast ... Invasive Breast...	Insertion of su... Adaptive skin s...	- 75 Years	National Institute of Oncology, Hungary
CONFIRM: Magnetic Resonance Guided Radiation Therapy	NCT04368702	Gastric Cancer Invasive Breast... in Situ Breast ... Mantle Cell Lym... Larynx Cancer Bladder Cancer	Viewray MRIdian...	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for in situ breast cancer